QC Chemist I

Reliability Technician-Packaging

Sr Director of QA

Chemist Reviewer

Supply Chain Manager

Chemist III

Analytical Scientist II

Senior Scientist - Analytical R&D

Validation Engineer

Engineering Manager

Responsibilities: <ul><li>The Chemist I, under direct supervision, learns and performs QC laboratory chemical analyses of raw materials, in-process materials, stability and finished products, and testing to support process validation.</li><li>May participate in investigations.</li><li>Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing.</li><li>Conducts routine laboratory analyses: finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing.</li><li>Typical activities may include buffer/solution preparation, standard preparation and operating analytical instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc.&nbsp;</li><li>Uses laboratory software for analyses.</li><li>Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping</li><li>Cleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals.</li><li>Under close supervision, learns to troubleshoot basic instrument problems.</li><li>With guidance, participates in OOS/OOT/NOE and other investigations.</li><li>Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor.</li><li>May assist in drafting, editing, and reviewing SOPs and laboratory investigations.</li><li>Maintains assigned training records current and in-compliance.</li><li>May assist in the training of less senior laboratory staff.</li><li>Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting.</li><li>Document accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.</li><li>Follows internal processes related to controlled substances continuous.</li><li>Follows EH&amp;S procedures to ensure a safe work environment.</li><li>Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS continuous.</li></ul> Requirements: <ul><li>Minimal acceptable level of education, work experience and certifications required for the job.</li><li>Bachelor of Science Degree in chemistry, chemical engineering or related field with analytical chemistry coursework required.&nbsp;</li><li>Some pharmaceutical laboratory experience preferred.</li><li>Proficiency in a body of information required for the job.</li><li>e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>Proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc.&nbsp;</li><li>Basic knowledge of wet chemistry techniques.</li><li>Knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS.</li><li>Competency in Microsoft Office Suite.</li><li>Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li><li>Ability to display and analyze data in a logical manner.</li><li>Good verbal and written communication skills as well as good computer skills.</li><li>Attention to details and accurate record keeping.</li><li>Establish and maintain cooperative working relationships with others</li><li>Solid organizational skills.</li><li>Ability to take initiative, set priorities and follow through on assignments.</li><li>Physical &amp; mental requirements e.g., lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.</li><li>Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals</li><li>Must occasionally lift and/or move up to 15-25 lbs.</li><li>Ability to wear personal protective equipment, including respirators, gloves, etc.&nbsp;</li><li>Specific visions abilities are required by this job include close vision and color vision.</li><li>Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods.</li></ul>

Responsibilities: <ul><li>Develops and applies basic knowledge and skills in procedures, techniques, tools, materials and/or equipment needed for the position. </li><li>Focused on a limited range of activities.&nbsp;</li><li>Completes routine tasks that are typically embedded in SOPs, operational or technical work practices and guidelines. Learns to identify deviations from accepted practice or procedure.</li><li>Identifies and solves routine problems that involve direct application of skills and knowledge. Seeks the input and assistance of others.&nbsp;</li><li>Learns the responsibilities of being a team member. Participates as a team member. Collaborates primarily within the immediate work unit, which may be cross-functional.</li><li>Close supervision involving detailed instructions and requires regular checks on work performance.</li></ul> Requirements: <ul><li>HS diploma or equivalent with related certification, or HS diploma or equivalent with 2-4 years’ related experience.</li><li>Ability to use Blue Mountain for PM execution and utilization of Apple tablets to complete PMs and MSRs desired.&nbsp;</li><li>Ability to use and read test instruments.&nbsp;</li><li>Ability to learn pharmaceutical maintenance and cGMP processes.&nbsp;</li><li>Ability to learn to perform tasks and read basic schematics, technical drawings and/or blueprints.&nbsp;</li><li>Ability to learn set ups.&nbsp;</li><li>Identifies and solves routine problems that involve direct application of skills and knowledge. Seeks the input and assistance of others.</li></ul> Knowledgeable in one or more of the following areas: <ul><li>Electrical</li><li>Hydraulic</li><li>Pneumatics</li><li>Mechanical</li><li>PLCs</li><li>Basic math, writing skills, and excellent problem solving abilities.&nbsp;</li><li>Basic computer skills.&nbsp;</li><li>Ability to use hand tools safely.&nbsp;</li></ul>

Role Description: <ul><li>The Sr. Director of Quality Operations is responsible for the quality unit at the site and for oversight of all quality related activities.&nbsp;</li><li>The incumbent will be an integral member of the Site Leadership Team. The Sr.&nbsp;</li><li>Director is accountable to ensure that the systems, procedures and practices for pharmaceutical operations at the site comply with policies and the cGMP requirements of all major regulatory agencies that regulate the site (e.g. FDA/EMA, etc.).</li></ul> Responsibilities: <ul><li>Leads and oversees Quality Assurance, Quality Control, Stability and related site quality activities, including commercial and development products.</li><li>Quality Lead for regulatory inspections, client audits and the site internal and external audit program. Prepares and approves responses to all external audit findings and oversees direct implementation of corrective and preventative actions (CAPAs).</li><li>Manages the QC team to ensure the availability of materials and testing necessary to meet the scheduled production and the site’s monthly target numbers.</li><li>Directs the QA team to ensure the timely completion of investigations, batch record reviews and batch releases to meet the site’s monthly targeted delivery performance.</li><li>Co-leads the Site Quality Council with Site Head and manages monthly meeting.</li><li>Contributes to the review and implementation of quality agreements with clients, contractors, and suppliers.</li><li>Provides direction on state of quality, quality related issues and quality metrics for the site. Independently identifies and initiates functional and cross-functional projects/task teams on a pre-emptive or as needed basis.</li><li>Identifies and implements various strategic initiatives that drive cost control and cost reductions. Responsible for development of the Quality Unit budget and successful execution to achieve it.</li><li>Review and/or approve deviations, out-of-specification reports, formal investigations, complaint investigations; Corrective Action/Preventative Action (CAPA) program and other reports as necessary.</li><li>Oversees the Quality training team on GMP related employee and contractor training. Ensures the training program adequately provides the guidance, procedures, systems and documentation that demonstrates personnel have the experience and qualifications to perform their job.</li><li>Interfaces with the regulatory team to evaluate product changes and new product introductions at the site to ensure compliance.</li><li>Coaches, councils and mentors staff on job related activities and career development.</li><li>Evaluates quality staffing needs with major fluctuations in production volumes and growth opportunities with technical transfer and development projects. Provides adequate justifications for resources when applicable.</li></ul> Requirements: <ul><li>Bachelor’s degree in the physical sciences or engineering. MS or Ph.D. in scientific or healthcare discipline preferred, but not required.</li><li>15+ years of Pharmaceutical QA and QC experience, with demonstrated growth in responsibilities and expertise.</li><li>7+ years of experience managing all aspects of a Quality department and function.</li><li>Proven leadership and development of a staff of quality professionals.</li><li>Detailed knowledge of chemistry and manufacturing/packaging controls.</li><li>Extensive knowledge of cGMP requirements (21CFR Part 211 and/or ICH Q7).</li></ul>

Role Description: <ul><li>The Chemist III, under minimal supervision, performs QC laboratory chemical analyses of raw materials, in-process materials, stability and finished products, and testing to support process validation.&nbsp;</li><li>Has demonstrated competence in conducting all types of physical and chemical analyses (including complex analyses) using all equipment. Detects, conducts, and reports on OOS/OOT/NOE and other investigations.&nbsp;</li><li>Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing.&nbsp;</li><li>Participates in troubleshooting analyses and instrumentation. Trains less senior staff.&nbsp;&nbsp;</li></ul> Responsibilities: <ul><li>Conducts laboratory analyses according to approved test methods: finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing. Typical activities may include buffer/solution preparation, standard preparation and operating analytical instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc.&nbsp;</li><li>Uses laboratory software for analyses.</li><li>Reviews and approves laboratory test data and documentation for completeness and compliance.</li><li>Is alert to and detects abnormalities during performances of tests and reviews.</li><li>Elevates abnormalities to Supervisor</li><li>Performs lab methods transfer and participate in method validation/verification studies</li><li>Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping</li><li>Cleans lab working surfaces and dispose of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals.</li><li>Troubleshoots instrument/chromatography problems and identifies improvements/CAPAs.</li><li>Detects, conducts and reports on OOS/OOT/NOE and other investigations.</li><li>Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor and recommends a course of action.</li><li>Writes, edits and reviews SOPs and laboratory investigations.&nbsp;</li><li>Maintains assigned training records current and in-compliance.</li><li>Actively assumes/demonstrates responsibility in training others in good documentation practice, practical lab skills, and chemical theories, methodologies and procedures</li><li>Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting.</li><li>Document accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.</li><li>Follows internal processes related to controlled substances.</li><li>Follows EH&amp;S procedures to ensure a safe work environment.</li><li>Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS.</li></ul> Requirements: Education &amp; Experience: <ul><li>Bachelor of Science Degree in chemistry, chemical engineering or related field with 4+ years’ relevant analytical laboratory experience OR,</li><li>Master’s Degree in above disciplines with 2+ years’ relevant analytical lab experience.</li></ul> Knowledge: <ul><li>Has strong knowledge of laboratory software and has expanded knowledge of chromatographic software (e.g. Waters Empower, Agilent ChemStation and Sotax WinSotax), using custom fields, custom calculations and custom reports</li><li>Full proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc.</li><li>Thorough knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS</li><li>Has demonstrated competence in conducting chemical analyses</li><li>Strong knowledge of wet chemistry techniques</li></ul> Competency in Microsoft Office Suite Skills &amp; Abilities: <ul><li>Ability to critically review and analyze data, interpret information, and draw conclusions from relevant or missing information, reporting to management.</li><li>Ability to display and analyze data in a logical manner.</li><li>Strong verbal and written communication skills as well as good computer skills.</li><li>Strong attention to details and accurate record keeping.</li><li>Establish and maintain cooperative working relationships with others.</li><li>Solid organizational skills.</li><li>Ability to coach less senior staff and develop laboratory skills and ability.</li><li>Ability to take initiative, set priorities and follow through on assignments.</li></ul> Physical Requirements: <ul><li>Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals</li><li>Must occasionally lift and/or move up to 15-25 lbs.</li><li>Ability to wear personal protective equipment, including respirators, gloves, etc.&nbsp;</li><li>Specific visions abilities are required by this job include close vision and color vision</li><li>Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods</li></ul>

Responsibilities: <ul><li>Responsibilities include assess supply chain status of products, planning/executing goods movements (production and inbound goods) also ensuring completeness and accuracy of SAP data.</li><li>Participate in the review/confirmation of the demand forecast; assess inventory level of all finished goods based on the demand forecast; oversee and/or validate inventory planning at the manufacturing sites.</li><li>Work closely with the 3PL to ensure timely receipt of shipments.</li><li>Mediate the resolution of any delays in having product available for sale</li><li>Prepare monthly inventory report, analyze and highlight projected inventory concerns based on Supply Plan.</li><li>Act as a contact for any planning/inventory availability issues with the plant manufacturing and supply team.</li><li>Provide oversight on all relevant product launch activities, and effectively manage internal and external stakeholders to ensure alignment on resource requirements.</li><li>Routinely collaborate with department head to achieve cross company alignment with respect to product supply risk and upside, inventory management through all downstream nodes Ensure continuity of supply for all products</li><li>Analyze and manage adequate inventory levels per guidelines, provide internal stake holders analysis of low and excess inventory items</li><li>Create, manage, and facilitate regular meetings, including the development of agendas, issue written minutes, and follow up on action items</li><li>Provide logistics support, as needed, including coordination and prioritization of planned shipments as well as shipment tracking</li><li>Inventory management and Logistics tracking including coordination with brokers for relevant deliveries.</li><li>Support data analysis for RFP’s – weekly, monthly and annual RFP’s.</li><li>Aid in analysis and review of 3 PL warehousing cost and other operational and logistical expenses.</li><li>Aid in process improvement mechanisms to enhance service level and inventory management.</li><li>Support serialization track and trace project.</li><li>Aid in process improvement mechanisms to enhance service and inventory.</li></ul> Requirements: Desired Skills: <ul><li>Highly analytical skills with strong problem solving ability utilizing minimal supervision</li><li>Excellent interpersonal skills ; team player ability to bridge strong working relationships across multiple disciplines</li><li>Ability to work in a global business culture</li><li>Excellent communication, verbal and written</li><li>Bachelor’s degree, preferably in supply chain, operations or related discipline.</li><li>Atleast 3 years of relevant experience in Supply Chain in pharmaceutical industry(preferred)</li><li>Demonstrated expertise with MS tools including Excel, Word, and Power Point. Expertise using SAP desirable.</li><li>Ability to manage large volume of spreadsheet data</li></ul>

Responsibilities: <ul><li>The Chemist III, under minimal supervision, performs QC laboratory chemical analyses of raw materials, in-process materials, stability and finished products, and testing to support process validation.</li><li>Has demonstrated competence in conducting all types of physical and chemical analyses (including complex analyses) using all equipment. Detects, conducts, and reports on OOS/OOT/NOE and other investigations.</li><li>Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing. Participates in troubleshooting analyses and instrumentation. Trains less senior staff.&nbsp;</li><li>Conducts laboratory analyses according to approved test methods: finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing.</li><li>Typical activities may include buffer/solution preparation, standard preparation and operating analytical instruments: HPLC, UVVis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc.</li><li>Uses laboratory software for analyses.</li><li>Reviews and approves laboratory test data and documentation for completeness and compliance.</li><li>Is alert to and detects abnormalities during performances of tests and reviews.</li><li>Elevates abnormalities to Supervisor.</li><li>Performs lab methods transfer and participate in method validation/verification studies</li><li>Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping.</li><li>Cleans lab working surfaces and dispose of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals.</li><li>Troubleshoots instrument/chromatography problems and identifies improvements/CAPAs&nbsp;</li><li>Detects, conducts and reports on OOS/OOT/NOE and other investigations.</li><li>Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor and recommends a course of action.</li><li>Writes, edits and reviews SOPs and laboratory investigations</li><li>Maintains assigned training records current and in-compliance</li><li>Actively assumes/demonstrates responsibility in training others in good documentation practice, practical lab skills, and chemical theories, methodologies and procedures&nbsp;</li><li>Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting.</li><li>Document accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.</li><li>Follows internal processes related to controlled substances</li><li>Follows EH&amp;S procedures to ensure a safe work environment.</li><li>Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS</li></ul> Requirements: <ul><li>Bachelor of Science Degree in chemistry, chemical engineering or related field with 4+ years’ relevant analytical laboratory experience OR,</li><li>Master’s Degree in above disciplines with 2+ years’ relevant analytical lab experience.</li><li>Has strong knowledge of laboratory software and has expanded knowledge of chromatographic software (e.g. Waters Empower, Agilent ChemStation and Sotax WinSotax), using custom fields, custom calculations and custom reports.</li><li>Full proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc.</li><li>Thorough knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS.</li><li>Has demonstrated competence in conducting chemical analyses.</li><li>Strong knowledge of wet chemistry techniques.</li><li>Competency in Microsoft Office Suite</li><li>Ability to critically review and analyze data, interpret information, and draw conclusions from relevant or missing information, reporting to management</li><li>Ability to display and analyze data in a logical manner.</li><li>Ability to critically review, analyze data, interpret information, and draw conclusions from relevant or missing information.</li><li>Ability to display and analyze data in a logical manner.</li><li>Strong verbal and written communication skills as well as good computer skills.</li><li>Strong attention to details and accurate record keeping.</li><li>Establish and maintain cooperative working relationships with others.</li><li>Solid organizational skills.</li><li>Ability to coach less senior staff and develop laboratory skills and ability.</li><li>Ability to take initiative, set priorities and follow through on assignments</li></ul>

Responsibilities: <ul><li>The Senior Scientist, Analytical R&amp;D will independently lead analytical method develop and validation activities for assigned projects, develop and validate analytical methods, review DMFs/Technical documents, identify specification requirements and set up specifications/specification justifications for raw materials and finished products, develop and understand product stability to guide design of stability studies in support of registration batches, generate technical documents to support regulatory submissions, provide timely analytical support on deficiency responses and product approval inspections.&nbsp;</li><li>Independently lead analytical method develop and validation activities for assigned ANDA products.</li><li>Develop and validate analytical methods for release and stability testing.</li><li>Review and evaluate drug substance supplier’s technical documents and provide recommendation in API vendor selection.</li><li>Identify specification requirements and set up specifications and specification justifications for raw materials and drug products.</li><li>Resolve complex problems in method or product development.</li><li>Develop and understand product stability to guide design of stability studies in support of product registration.</li><li>Generate technical documents to support regulatory submissions.</li><li>Provide timely analytical support on deficiency responses and product approval inspections.</li><li>Review laboratory notebooks, raw data and technical documentation in support of regulatory filings.</li><li>Interact with other depts: Formulations, Regulatory Affairs, Production, Strategic Sourcing, etc., to support timely new product development/submission of new ANDAs.</li><li>Peer review of lab notebooks.</li><li>Evaluate, troubleshoot/improve existing analytical methods when necessary.</li><li>Continuously update knowledge of latest technologies related to analytical science.</li><li>Work in compliance with cGMP/cGLP regulations.</li></ul> Requirements: <ul><li>PhD in scientific discipline + min. 3 yrs. in pharmaceutical analytical chemistry or related field, with hands-on knowledge of current analytical techniques OR</li><li>MS + min. 5 yrs. OR BS with 7 yrs.</li><li>Strong knowledge of analytical chemistry and concepts in developing and validating methods to meet correct pharmaceutical standards.</li><li>Superior knowledge of major analytical techniques such as HPLC/UPLC, dissolution, FT-IR, physical characterization, etc.</li><li>Strong knowledge of FDA, ICH, and USP guidance and regulations.</li></ul>

Responsibilities: <ul><li>Independently lead analytical method develop and validation activities for assigned ANDA products.</li><li>Develop and validate analytical methods for release and stability testing.</li><li>Review and evaluate drug substance supplier’s technical documents and provide recommendation in API vendor selection.</li><li>Identify specification requirements and set up specifications and specification justifications for raw materials and drug products.</li><li>Resolve complex problems in method or product development.</li><li>Develop and understand product stability to guide design of stability studies in support of product registration.</li><li>Generate technical documents to support regulatory submissions.</li><li>Provide timely analytical support on deficiency responses and product approval inspections.</li><li>Review laboratory notebooks, raw data and technical documentation in support of regulatory filings.</li><li>Interact with other depts: Formulations, Regulatory Affairs, Production, Strategic Sourcing, etc., to support timely new product development/submission of new ANDAs.</li></ul> Requirements: <ul><li>Peer review of lab notebooks.</li><li>Evaluate, troubleshoot/improve existing analytical methods when necessary.</li><li>Continuously update knowledge of latest technologies related to analytical science</li><li>Work in compliance with cGMP/cGLP regulations.</li><li>Strong knowledge of analytical chemistry and concepts in developing and validating methods to meet correct pharmaceutical standards.</li><li>Superior knowledge of major analytical techniques such as HPLC/UPLC, dissolution, FT-IR, physical characterization, etc.</li><li>Strong knowledge of FDA, ICH, and USP guidance and regulations.</li></ul>

Responsibilities: <ul><li>The Validation Engineer works alone and as part of the Engineering Department to author and execute IQ/OQ/PQ protocols, engineering studies, facility qualifications and other documents related to production and business systems.</li><li>They will also be responsible for engineering and maintenance projects, such as repairs, upgrades or replacements as the need arises.</li><li>They will work with quality, technical operations and production to identify and resolve issues.&nbsp;</li><li>Adhere to all company and cGMP procedures as well as applicable safety regulations.</li><li>Author change controls, SOPs and protocols.</li><li>Protocols o Generates and executes validation protocols, and summarizes studies to ensure compliance with manufacturer and SPI specifications, with current Good Manufacturing Practices, and national standards.</li><li>Responsible for confirming all communicated validation plans to applicable management.</li><li>Provides technical assistance in the form of rationales or validation studies.</li><li>Responsible for effectively adopting modern validation techniques, current industry practices, risk management principles, science-based approaches and a strong understanding of processes and equipment.</li><li>Troubleshoots and resolves issues as needed.</li><li>Manage multiple projects with competing deadlines.</li><li>Manage external resources to complete tasks outside SPI’s capabilities.&nbsp;</li><li>Manage approvers of documents and procedures and ensure timely closure of tasks.</li><li>Manage project-related Change Requests form initiation through closure, including presentation to Change Control Committee.</li><li>Assist with deviation investigation and identify areas for CAPAs as needed based on root causes.</li><li>Source and procure equipment, supplies and other materials as needed.</li><li>Develop and maintain cross-functional relationships.&nbsp;</li></ul> Requirements: <ul><li>Bachelor of Science in Engineering or Science discipline preferred.</li><li>Experience in pharmaceutical (i.e. Validation/QA or R&amp;D), medical device, biotechnology industries.</li><li>In-depth knowledge of the pharmaceutical plant operations is an asset.</li><li>Proficient in Microsoft Word, Excel, Power Point, Project, AutoCAD and other software relevant to the performance of the Job</li><li>Experience authoring change controls in Trackwise or other management system.</li><li>Experience authoring SOPs in MasterControl or other management system.</li><li>Integrity – Works with integrity and ethically; Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.</li><li>Collaboration – Works well in group problem solving situations; Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions.&nbsp;</li><li>People – Treats people with respect; Keeps commitments; inspires the trust of others; Demonstrates knowledge of EEO policy; Shows respect and sensitivity for cultural differences; promotes a harassment-free environment.</li><li>Responsive – Identifies and adapts to priority issues as they arise; Communicates with management and team members effectively; Works quickly and efficiently.</li><li>Proactive – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions.</li><li>Organized – Tracks deadlines and adheres to schedules; Writes clearly and informatively; Presents numerical data effectively.</li><li>Learning Mindset – Adapts to unfamiliar situations as needed; Open to new ideas and methods; Readily familiarizes self with new equipment and processes.</li><li>Regularly lift and /or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.</li><li>Climb ladders and work in high, precarious places up to elevations of 75 feet.</li><li>Regularly exposed to work near moving mechanical parts.</li><li>Exposed to wet or humid conditions.</li><li>Exposed to outdoor weather conditions.</li><li>Regularly exposed to high noise environments.</li><li>Exposed to extremely dusty environments.</li><li>Exposed to chemicals used in the manufacturing process.</li></ul>

Responsibilities: <ul><li>The Manager, Engineering leads projects to develop engineering solutions for operational issues or new processes.&nbsp;</li><li>This position implements system improvements of capital projects, establishes engineering project objectives and technical criteria for evaluating project results and activities of project team, develops processes that lead to shortened cycle time and makes impact decisions while supporting the policies, goals and objectives of the company.</li><li>Participate in objective setting, plan development and performance review of plant performance</li><li>Develops, plans, coordinates and directs engineering aspects of projects of major scope and importance</li><li>Defines roles and accountabilities to avoid duplicate functions</li><li>Reviews and approves IQ/OQ/PQ test documents, SOPs and Preventative Maintenance work plans for new/upgrade equipment and systems</li><li>Manages external engineering services and recommends resources required to carry out projects or improvements</li><li>Routinely has direct contact with outside consultants, technical counterparts from key vendors Budget monitoring, control, and trend tracking</li><li>Responsible for maintaining qualified state of all active equipment and systems</li><li>Administers key systems including CCMS/CMMS, EMS</li><li>Prepares and maintains departmental policies, SOPs and document templates</li><li>Controls revisions of critical facility and utility drawings</li><li>Acts as subject matter expert during inspection and audits</li><li>Supports safety, health, and environmental policies and procedures</li><li>Works with Environmental Health and Safety to ensure city, county, state, and federal regulations relating to the projects and process improvements are met at all times</li><li>Directs, and enforces the safety program for the engineering group and reviews safety records to uphold standards of maximum safety for all maintenance and calibration staff</li><li>Coordinates activities with manufacturing, packaging, logistics, research and development, technical services and IT Departments</li><li>Communicates directly with the operations departments to coordinate engineering activities</li><li>Communicates directly with QA and QC laboratory to ensure effective participation by engineering staff in the implementation of QA policies and procedures</li><li>Communicates regularly with all engineers, both individually and as a group, to ensure good two-way communication concerning operational improvements and projects</li><li>Assists with planning and implementing plant improvements and expansions</li><li>Prepares reports, analyzes data, and makes recommendations for improving plant operations and solving manufacturing/packaging-related problems</li><li>Initiates and carries out projects that improve efficiency and/or reduce operating costs</li><li>Coordinates with maintenance and operations staff in reviewing the operation of plant equipment and systems to minimize unplanned downtime, anticipate solve problems in a timely manner, and to identify opportunities for improvement</li><li>Assists with deviation investigation and identifies areas for CAPAs as needed based on root causes.</li><li>Sources and procures equipment, supplies and other materials as needed.</li></ul> Requirements: <ul><li>Bachelor of Science in Engineering or Science discipline preferred</li><li>3 years of experience in pharmaceutical engineering, pharmaceutical operations, and operations management</li><li>In-depth knowledge of the pharmaceutical plant operations is an asset</li><li>AutoCAD</li><li>CCMS/CMMS software (Blue Mountain Regulatory Asset Manager)</li><li>EMS/BMS</li><li>PLC programming and electrical troubleshooting</li></ul>

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12 chestnut ridge Jobs found

QC Chemist I

Reliability Technician-Packaging

Sr Director of QA

Chemist Reviewer

Supply Chain Manager

Chemist III

Analytical Scientist II

Senior Scientist - Analytical R&D

Validation Engineer

Engineering Manager

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12 chestnut ridge Jobs found

QC Chemist I

Reliability Technician-Packaging

Sr Director of QA

Chemist Reviewer

Supply Chain Manager

Chemist III

Analytical Scientist II

Senior Scientist - Analytical R&D

Validation Engineer

Engineering Manager

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

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WhiteCrow
WhiteCrow is on a mission to connect companies with the best talent across the globe.