Senior Quality & Reliability Engineer

IBM Infosphere DataStage Developer

Technical Writer

Senior Frontend Engineer

Validation Manager

Manager – ADL GMP

Senior Consultant – Commercial Solutions

Global Construction Manager

Director, Engineering Services

Manager, Operations

Responsibilities: Quality System &amp; Compliance <ul><li>Develop and implement quality and reliability processes to support NPI.</li><li>Lead the development and scaling of the site Quality Management System (QMS).</li><li>Ensure QMS elements (management reviews, internal audits, supplier management) comply with global standards.</li><li>Act as Lead Auditor for internal audits and ensure compliance with ISO 13485 and FDA QSR.</li><li>Support external audits, including preparation, mock audits, and corrective actions.</li><li>Review and approve ECOs, DCOs, training matrices, and other NPI documentation.</li><li>Maintain updated quality policies and procedures aligned with evolving standards.</li></ul> NPI Planning &amp; Execution <ul><li>Represent Quality in customer meetings and business reviews.</li><li>Collaborate with cross-functional teams including engineering, manufacturing, PMO, and supply chain.</li><li>Support implementation of electronic quality systems for improved traceability and documentation.</li><li>Evaluate product development objectives to identify quality improvement opportunities.</li><li>Create, review, and maintain quality system documents specific to NPI.</li><li>Calculate and present NPI quality KPIs.</li></ul> Continuous Improvement &amp; Problem Solving <ul><li>Lead or support quality system improvement projects.</li><li>Use statistical and scientific methods to analyze data and drive improvements.</li><li>Provide expertise in CAPA, root cause analysis, and reliability engineering tools.</li><li>Facilitate cross-functional improvement teams focused on NPI processes.</li></ul> Training &amp; Leadership <ul><li>Conduct training in GDP, GMP, CAPA, and compliance topics.</li><li>Oversee CAPA investigations to ensure true root cause identification and effective corrective actions.</li><li>Supervise and mentor Quality Engineers supporting NPI initiatives.</li></ul> Requirements: Required Skills &amp; Competencies Core Competencies <ul><li>Strong technical learning ability</li><li>Excellent problem-solving and analytical thinking</li><li>High ethical standards and integrity</li><li>Action-oriented and self-driven</li></ul> Job-Specific Skills <ul><li>Knowledge of NCMRs, CARs, CAPA, customer complaints, RMA metrics, DPPM, and DLPM</li><li>Strong technical "hands-on" skills</li><li>Excellent communication and interpersonal abilities</li><li>Ability to manage multiple tasks in a fast-paced environment</li><li>Strong prioritization and organizational skills</li><li>Proficiency in Microsoft Office (Word, Excel, PowerPoint, Visio)</li><li>Advanced technical report writing skills</li><li>Strong understanding of ISO 13485 and FDA QSR</li><li>Bilingual English (Advanced) / Spanish preferred</li><li>Willingness to travel up to 20% (based in Costa Rica)</li></ul> Experience &amp; Education <ul><li>Experience: 5+ years of Quality leadership experience in a manufacturing environment, preferably in multinational settings and NPI roles.</li><li>Education: Bachelor’s degree in a scientific or engineering discipline.</li><li>Certifications: CQE/CSSBB certification preferred.</li></ul>

Responsibilities: <ul><li>Design, develop, and implement ETL processes using IBM InfoSphere DataStage to extract data from various source systems, transform it according to business rules, and load it into target data warehouses and data marts.&nbsp;&nbsp;</li><li>Develop and maintain DataStage jobs, sequences, and workflows, ensuring optimal performance and scalability.</li><li>Troubleshoot and resolve data integration issues, working closely with data analysts and other stakeholders.</li><li>Write and execute complex SQL queries to analyze data, profile data sources, and validate ETL processes.</li><li>Collaborate with business analysts and data architects to understand data requirements and translate them into technical specifications.&nbsp;&nbsp;</li><li>Participate in the full software development lifecycle, including requirements gathering, design, development, testing, deployment, and documentation.&nbsp;&nbsp;</li><li>Ensure adherence to data governance policies and standards.</li><li>Monitor ETL processes and proactively identify and address potential performance bottlenecks.</li><li>Contribute to the development and maintenance of technical documentation, including design specifications, mapping documents, and operational procedures.</li></ul> Requirements: <ul><li>Minimum of 3 to 5 years of hands-on experience in designing, developing, and implementing ETL solutions using IBM InfoSphere DataStage.</li><li>Strong understanding of ETL concepts, methodologies, and best practices.</li><li>Proficiency in writing complex SQL queries and working with relational databases, preferably Oracle.</li><li>Experience with data modeling concepts (e.g., dimensional modeling, star schema, snowflake schema).</li><li>Familiarity with Linux operating systems and basic Linux commands is a plus.</li><li>Exposure to OBIEE (Oracle Business Intelligence Enterprise Edition) or other business intelligence tools is a plus.</li><li>Excellent written and verbal communication skills, with the ability to effectively communicate technical concepts to both technical and non-technical audiences.&nbsp;&nbsp;</li><li>Excellent analytical skills and technical skills, with a strong attention to detail and problem-solving abilities.</li><li>Bachelors degree in Computer Science or equivalent in education and work experience.</li></ul>

Responsibilities: <ul><li>Develop and maintain comprehensive documentation for smart contract applications, including user guides, API references, and system overviews.</li><li>Collaborate with engineering and product teams to understand new features and translate them into accurate and accessible documentation.</li><li>Create tutorials, walkthroughs, and FAQs to support users and developers interacting with our applications.</li><li>Ensure documentation is consistent with brand voice, technical accuracy, and usability standards.</li><li>Maintain version control and change logs for documentation updates.</li><li>Organize and manage documentation repositories using tools like Git, Notion, or Confluence.</li><li>Conduct user research and gather feedback to improve documentation quality and relevance.</li><li>Stay current with Web3 trends, tools, and best practices to ensure documentation reflects the latest standards and innovations.</li></ul> Requirements: <ul><li>3+ years of experience in technical writing, preferably in software or blockchain environments.</li><li>Strong understanding of Web3 technologies, including smart contracts, dApps, and blockchain fundamentals.</li><li>Experience documenting APIs, SDKs, and developer tools.</li><li>Proficiency with documentation tools such as Markdown, Git, and static site generators.</li><li>Excellent written and verbal communication skills.</li><li>Ability to work independently and manage multiple documentation projects simultaneously.</li><li>Strong attention to detail and commitment to clarity and accuracy.</li></ul> Bonus Experience: <ul><li>Experience working with smart contracts</li><li>Familiarity with Solidity, Rust, or other smart contract languages.</li><li>Experience with Chainlink tools, including CCIP, Data Feeds, VRF, and Automation.</li><li>Background in UX writing or instructional design.</li><li>Contributions to open-source documentation or developer communities.</li><li>Experience in financial services or regulated industries.</li></ul>

Responsibilities: <ul><li>Create and implement interactive, user-friendly, and visually appealing user interfaces (UIs) for web applications.</li><li>Develop robust front-end architectures, write high-quality code, and perform code reviews to maintain standards.&nbsp;</li><li>Ensure applications are fast, responsive, and scalable across various devices and platforms by optimizing loading times and performance.&nbsp;</li><li>Research, evaluate, and adopt new front-end technologies and frameworks (Angular, React) to keep products at the groundbreaking.&nbsp;</li><li>Collaborate with our team to create user-friendly web3 applications.</li><li>Develop responsive and intuitive UIs with React, Next.js, HTML, CSS, and JavaScript/TypeScript.</li><li>Work with WAGMI, Viem to interact with smart contracts.</li><li>Work with Redux and/or MobX for smooth state management.</li><li>Work with REST APIs and GraphQL for backend communication.</li></ul> Requirements: <ul><li>Proven experience as a senior frontend engineer, with a track record of delivering high-quality web applications.</li><li>Strong proficiency in JavaScript/TypeScript languages.</li><li>Expertise in frontend frameworks: Angular and/or React.</li><li>Hands-on experience with RxJS library and state management systems: NGRX, NGXS.</li><li>Experience in writing and support unit tests (Karma, Jasmine, Spectator).</li></ul>

Responsibilities: <ul><li>Serve as the site Validation SME, overseeing all validation activities, including process, cleaning, equipment, utility, and computer system validation.</li><li>Own and maintain the Validation Master Plan (VMP), ensuring alignment with regulatory expectations, site activities, and company objectives.</li><li>Develop, implement, and maintain the site validation lifecycle program, including process validation, performance qualification (PQ), and CPV.</li><li>Lead validation planning and coordination efforts for new equipment, systems, and process changes in collaboration with Engineering, Manufacturing, and Quality.</li><li>Manage validation project timelines and resource allocation, ensuring activities support commercial readiness and ongoing operations.</li><li>Review and approve validation protocols, reports, and risk assessments in compliance with FDA, EMA, ICH Q8-Q10, EU Annex 15, and company standards.</li><li>Support and participate in cross-functional risk assessments (e.g., FMEA) related to qualification and validation efforts.</li><li>Ensure validation documentation is complete, accurate, and audit ready.</li><li>Provide guidance and technical expertise during regulatory inspections, audits, and customer assessments.</li><li>Develop and maintain the site’s Continuous Process Verification (CPV) program to monitor validated state and process performance over time.</li><li>Define and monitor KPIs for validation program effectiveness and drive improvements in validation efficiency and compliance.</li><li>Train and mentor staff on validation principles and procedures to build internal capability across departments.</li><li>Ensure change control, deviation management, and CAPA processes integrate appropriately with validation and qualification requirements.&nbsp;</li></ul> Key Stakeholders: Internal: <ul><li>Site Quality, Manufacturing, and Engineering Teams</li><li>Technical Services, Supply Chain, and EHS</li><li>Validation Analysts and Support Staff</li><li>Corporate Validation and Quality Teams</li></ul> External: <ul><li>Regulatory Agencies (FDA, EMA, etc.)</li><li>Equipment and system vendors</li><li>Contract testing laboratories</li><li>Third-party auditors and certifying bodies</li></ul> Requirements; Qualifications / Experience: <ul><li>Bachelor’s degree in engineering, Life Sciences, Pharmacy, or related discipline; Master’s preferred</li><li>Minimum 10-12 years of experience in pharmaceutical or biotechnology validation, with at least 3 years in a leadership or SME role</li><li>Validation of sterile injectable equipment expertise required</li><li>Strong knowledge of FDA cGMPs, ICH Q8–Q10, EU Annex 15, and validation best practices</li><li>Experience with sterile injectable manufacturing, aseptic processes, utilities, and equipment qualification</li><li>Experience with controlled substances and high-potency compounds preferred</li><li>Proven experience supporting regulatory inspections and third-party audits</li><li>Experience with commissioning, qualification, and validation in a startup (greenfield) or expansion environment preferred </li></ul> Skills / Competencies: <ul><li>Strong technical writing and documentation review skills</li><li>Ability to manage multiple projects and prioritize in a fast-paced environment</li><li>Expertise in sterile systems, process validation, cleaning validation, and computer system validation</li><li>Excellent cross-functional communication, influencing, and collaboration skills</li><li>Strong analytical, risk-based decision-making, and problem-solving skills</li><li>Leadership presence with ability to coach and mentor others in validation principles</li><li>Commitment to data integrity, patient safety, and product quality</li></ul>

Role Description: <ul><li>The Manager –ADL, GM P is responsible for leading analytical development activities within a GMP-regulated environment, ensuring robust method development, validation, and transfer for pharmaceutical products.</li><li>This role plays a critical part in supporting product development, regulatory submissions, and commercial manufacturing by providing accurate and compliant analytical data.</li></ul> Responsibilities <ul><li>Lead and manage a team involved in method validation, method transfer, and postproduction studies (Freeze Thaw analysis, Photostability studies, Dilution studies, RLD Characterization, etc.) for 505b(2) and generic ANDAs.</li><li>Troubleshoot and resolve challenges during method validation and method transfer of new products from R&amp;D to manufacturing sites.</li><li>Support regulatory filings and respond to analytical function queries.</li><li>Ensure compliance with cGLP within the ADL GMP function.</li><li>Provide support during quality inspections by regulatory agencies at manufacturing plants.</li><li>Timely closure of LIR, NCR, CCN, CAPA and ensure implementation of corrective and preventive actions.</li><li>Ensure timely compliance with Pharmacopoeia updates.</li><li>Mentor, coach, and develop team members for task execution and personal growth.</li><li>Collaborate with external partners (CRO/CMO) for analytical testing execution.</li><li>Work cross-functionally with project management, regulatory affairs, formulation development, manufacturing, and quality control teams.</li></ul> Requirements: <ul><li>Education: Ph.D. OR MPharm.</li><li>Experience: 3–4 years of team handling experience.</li></ul> Skills Required: <ul><li>Strong knowledge of analytical method validation, method transfer, Pharmacopoeia compliance, cGLP, and documentation practices.</li><li>Sound understanding of analytical techniques with good learning agility.</li><li>Excellent technical writing and computer skills for data recording, protocol/report generation, and presentations.</li><li>Strong coordination, relationship management, and ability to work in multicultural teams.</li><li>Effective communication and team management skills.</li><li>Knowledge of latest quality and regulatory requirements.</li><li>Ability to delegate effectively and take autonomous decisions.</li><li>Critical thinking skills for problem-solving and decision making.</li></ul>

The RoleTo provide expertise, advice, support, report on, and lead large scale/complex supply chain solution projects that optimises organisational value chain integration and performance, underpinned by supply chain and logistics capabilities. The Senior Consultant is experienced in leading cross-functional teams, conducting analysis, providing recommendations and guidance towards the delivery of strategic multiple large-scale supply chain solutions projects. Expected to work closely with clients to understand their business needs, identify opportunities for improvement and design solutions to optimise their supply chains. Manages and balance the requirements between business objectives and project requirements.&nbsp;Recognise trends, patterns, or themes in complex data, and leverages experience to solve complex problems.&nbsp;Understands the importance of project governance, stakeholder management, commercial models, and managing project teams. Key Responsibilities·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Grow clients and revenue.·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Overseer quality of analysis and solution teams outputs ·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Design the test methodology and success criteria for value-chain improvement solutions across multiple capabilities and regions.·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Facilitate cross functional business improvement and solutions development workshops.·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Obtain and document client requirements to enable design of integrated fit-for-purpose business solutions that improve client’s value chain.·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Support management of prospective client pipeline by evaluating and qualifying solution leads·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Project team performance management Minimum RequirementsQualifications required&nbsp;<ul><li>B.Eng Industrial or BCom Logistics (Honours) or BCom Supply Chain Management (Honours) [NQF level 7 or higher]&nbsp;</li></ul>Skills and experience required<ul><li class="ql-align-justify">8 - 12 years relevant work experience (operations and/or solution design role)</li><li class="ql-indent-1 ql-align-justify">Applies supply chain management knowledge, solves problems in the supply chain using this knowledge.</li><li class="ql-align-justify">Proven track record of leadership and managing project teams</li><li class="ql-indent-1 ql-align-justify">The ability to inspire, motivate and direct individuals to take ownership of-, and achieve desired outputs.</li><li class="ql-indent-1 ql-align-justify">Establishes an atmosphere of trust and mutual respect between team members. </li><li class="ql-indent-1 ql-align-justify">Clearly articulates a goal and purpose to ensure alignment of team members towards a desired objective.</li><li class="ql-indent-1 ql-align-justify">Manages performance of team members.&nbsp;&nbsp;</li><li class="ql-indent-1 ql-align-justify">Provides performance feedback to team members in a constructive manner</li><li class="ql-align-justify">Proven track record of delivering successful projects</li><li class="ql-indent-1 ql-align-justify">The ability to ensure high standards of accuracy, quality, and service delivery to meet and exceed client expectations.</li><li class="ql-indent-1 ql-align-justify">Applies knowledge, tools, and technical expertise to support value creation, tailoring it to the specific needs of the client.</li><li class="ql-align-justify">Thorough understanding of capabilities offered by our client.</li><li class="ql-align-justify">Understanding of financial and management accounting (commercial models).</li><li class="ql-align-justify">Demonstrated understanding of supply chain costs, cost drivers and cost efficiencies levers.</li><li class="ql-align-justify">Ability to review business analysis process and deliverables in order to recommend improvements.</li><li class="ql-align-justify">Exceptional analytical skills.</li><li class="ql-align-justify">Creating &amp; delivering professional presentations.</li><li class="ql-align-justify">Written and verbal communication, including technical writing skills.</li><li class="ql-align-justify">Time management: comfortable working under pressure with stringent deadlines and complex deliverables. Flexible hours to achieve deliverables (sometimes required to work in addition to/outside of normal business hours).</li><li class="ql-align-justify">Plan, manage and account for own time according to tasks’ priorities with a high attention to detail.</li><li class="ql-align-justify">Self-motivated and proactive.</li><li class="ql-align-justify">Able to think logical and objectively with the ability to be innovative in approach and solution design / problem solving.</li><li class="ql-align-justify">Willingness to travel (predominantly Africa, ad-hoc).</li></ul>

Responsibilities:&nbsp; <ul><li>Manage daily activities associated with large &amp; small-scale construction, renovation, expansion, and relocation/consolidation projects. Manage projects from inception through completion, being the primary point of contact for all project-related activities</li><li>Schedule and conduct various construction-related meetings with Architect/Engineer (AE) firms, contractors, facilities, and internal project teams to develop, review, and finalize scope, site and building plans, specifications, construction schedule, construction costs, material delivery, inspection issues, and critical dates. </li><li>These meetings include but are not limited to scope development, design, pre-construction, pre-bid, construction progress, and punch list.</li><li>Observe work in progress on each project to ensure that standard construction practices and procedures are in place and that all work conforms to design drawings, specifications, budget, and schedules. </li><li>Requires ongoing site visits and weekly or semi-weekly updates.</li><li>Create, maintain, and regularly update electronic project files, including but not limited to progress reports, photos, budgets, schedules, proposals, bids, purchase orders, and project correspondence.&nbsp;</li><li>Possess a solid ability to manage multiple projects at one time.</li><li>Inspect the quality of the completed installation, including punch list items, and receive a certificate of occupancy.&nbsp;</li></ul> Requirements: <ul><li>&nbsp;Bachelors degree in Architectural Engineering or Construction/Project Management from a four-year College or university and 5+ years of related experience.</li><li>Ability to read and interpret documents such as architectural and engineering construction plans, specifications, operating and maintenance instructions, and procedure manuals.</li><li>Ability to write routine reports and correspondences</li><li>Ability to communicate and interact verbally and in writing with other related field project team members: Architects, Drafters, Engineers, Developers, Real Estate Managers, Contractors, Subcontractors, and Vendors.</li></ul>

Role Description: <ul><li>The Director, Engineering Services leads engineers and maintenance staff to maintain the existing facilities and equipment while developing engineering solutions to operational issues or new processes.</li><li>This position implements capital projects, establishes engineering project objectives and technical criteria for evaluating project results and activities of project team while supporting the policies, goals and objectives of the Company.</li></ul> Responsibilities: Engineering Project Management and Qualification <ul><li>Member of Site Leadership Team</li><li>Develops, plans, coordinates and directs engineering aspects of projects of major scope and importance</li><li>Manages IQ, OQ, PQ program. ?	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</li></ul> Facilities and Equipment Maintenance&nbsp; <ul><li>Directs the maintenance staff for routine PM and unplanned repairs of facilities and production equipment.</li><li>Manages calibrations within the plant through in-house or contract services.</li><li>Supports Serialization within the plant.</li></ul> Cross Functional Coordination&nbsp; <ul><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></ul> Plant/Process Improvement&nbsp; <ul><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></ul> Supervisory Responsibilities&nbsp; <ul><li>Conducts employee performance reviews based on job descriptions to determine competency, knowledge, and contribution of the engineering staff</li><li>Ensures that all engineering staff are trained on the most updated version of the operating procedures</li></ul> Requirements: Education &amp; Experience <ul><li>Bachelor of Science in a related technical field plus progressive technical experience and demonstrated competence</li><li>10 years progressive management experience in pharmaceutical engineering, pharmaceutical operations, and operations management</li></ul> Knowledge In-depth knowledge of the pharmaceutical plant operations is an asset Skills &amp; Abilities <ul><li>Managing People - Includes staff in planning, decision-making, facilitating and process improvement; Takes responsibility for subordinates activities; Makes oneself available to staff; Provides regular performance feedback; Develops subordinates skills and encourages growth; Solicits and applies customer feedback (internal and external); Fosters quality focus in others; Improves processes, products and services.; Continually works to improve supervisory skills.</li><li>Leadership - Exhibits confidence in self and others; Inspires and motivates others to perform well; effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others.</li><li>Analytical -Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures.</li><li>Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.</li><li>Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyones efforts to succeed.</li><li>Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others ideas and tries new things.</li><li>Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.</li><li>Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.</li></ul> Physical Requirements <ul><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 Engineering</li></ul>

Role Description:&nbsp; <ul><li>The purpose of this job is to oversee the production schedules in accordance with approved production instructions, standard operating procedures, while utilizing cGMP for the preparation of commercial product.</li><li>Monitor and document in a periodic performance review the performance of the production staff. Identify opportunities for process and equipment improvements.</li><li>Mentor staff and set goals and objectives for the production personnel.</li></ul> Responsibilities: <ul><li>Manufacturing Operations Management</li><li>Assure the accurate execution of cGMP/DEA documentation relative to manufacturing and packaging activities.</li><li>Assure the accurate manufacturing of bulk drug product for delivery to primary packaging without deviation.</li><li>Assure the accurate packaging of drug product in approved primary packaging components without deviation</li><li>Assure the accurate sampling of raw material and the packaging of samples for shipment as appropriate to contract testing laboratories.</li><li>Assure the accurate assessment of component inventory and reconciliation.</li><li>Assure staff training requirements are established and complete prior to the performance of process or procedure.</li><li>Assure the accurate performance of basic routine preventive maintenance of equipment and facility cleaning activities by operators.</li><li>Establish performance Goals and Objectives based on facility needs and High Corporate Standards.</li><li>Complete routine performance evaluations of staff, and recommend growth opportunities.</li><li>Assure adherence to established production schedules and monitor production performance as determined by the Plant Director.</li><li>Monitor the general safety of staff and assure safe work practices are followed by all site personnel.</li></ul> Requirements: Education &amp; Experience <ul><li>Undergraduate Degree in Pharmacy, Engineering, or equivalent in training and experience.</li><li>10 years’ experience in a pharmaceutical manufacturing environment.</li><li>Prior cGMP experience in a pharmaceutical production environment is necessary. 3-5 years’ previous supervisory experience required.</li><li>Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li></ul> Knowledge&nbsp; <ul><li>Knowledge of workplace health and safety requirements for applicable hazardous substances.</li><li>Must be able to demonstrate a high degree of understanding in the cGMP practices.</li><li>Must be able to demonstrate a high degree of understanding in the controlled drug substance regulations.</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></ul> Skills &amp; Abilities <ul><li>Demonstrate knowledge of the current good manufacturing practices.</li><li>Ability to convey information clearly and concisely to both individuals and groups.</li><li>Ability to troubleshoot manufacturing processes, write investigations and complete documentation.</li><li>Ensure adequate staffing and efficient workflow and provide reports and data on manufacturing activity.</li></ul> Physical Requirements	 <ul><li>This position requires working with or around hazardous substances, and is subject to work restrictions and precautions as set forth in the Safety Data Sheet, provided to all affected employees.</li><li>Ability to don personal protective equipment, if necessary. Able to walk the production floor.</li><li>This position requires working with or around hazardous substances, and is subject to work restrictions and precautions as set forth in the Safety Data Sheet, provided to all affected employees.</li><li>Ability to don personal protective equipment, if necessary.</li><li>Able to walk the production floor.</li></ul>

Skills

Industry

Location

Jobtitle

26 writing Jobs found

Senior Quality & Reliability Engineer

IBM Infosphere DataStage Developer

Technical Writer

Senior Frontend Engineer

Validation Manager

Manager – ADL GMP

Senior Consultant – Commercial Solutions

Global Construction Manager

Director, Engineering Services

Manager, Operations

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

EMPLOYER

TALENT

COMPANY

Contact Us

JOBS BY SKILLS

JOBS BY FUNCTION

JOBS BY INDUSTRY

JOBS BY LOCATIONS

MODEL JOBS

JOBS BY CITY

Skills

Industry

Location

Jobtitle

26 writing Jobs found

Senior Quality & Reliability Engineer

IBM Infosphere DataStage Developer

Technical Writer

Senior Frontend Engineer

Validation Manager

Manager – ADL GMP

Senior Consultant – Commercial Solutions

Global Construction Manager

Director, Engineering Services

Manager, Operations

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

EMPLOYER

TALENT

COMPANY

Contact Us

JOBS BY SKILLS

JOBS BY FUNCTION

JOBS BY INDUSTRY

JOBS BY LOCATIONS

MODEL JOBS

JOBS BY CITY

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