Manager – ADL GMP

Reference Standard Coordinator

Field Service Engineer

Manufacturing Engineer

Manufacturing Technician V (Senior Technician)

Supervisor III, Production

Learning Management Specialist

Process Mechanic – Sterile Filling & Packaging

Facility Mechanic

Facility Engineer

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>

Responsibilities: Sample Management <ul><li>Performs QC reference standard/chromatographic column receipt, processing, distribution for testing and storage.</li><li>Performs QC reference standard reconciliation and disposal.</li><li>Tracks inventory of reference standards in the lab.</li><li>Uses laboratory software for reference standard, chromatographic column management.</li><li>Verifies accuracy of labeling/documentation provided with reference standards.</li><li>Informs QC Coordinator if chemical or reference standard is expired for removal from laboratory area.</li><li>Coordinates, with lab management, in-house qualification of reference standards. Submit samples to the appropriate lab groups for testing.</li><li>Create and maintain reports including quality data trending, informational spreadsheets, laboratory log spreadsheets.</li><li>Compile a list of necessary laboratory supplies specifically reference standards, contacting vendors to obtain quotes.</li><li>Uses the purchasing system to procure reference standards and laboratory supplies.</li><li>Provide status updates to QC management and other departments regarding the status of reference standard inventory.</li><li>Maintain a safe work environment by following standards and procedures and complying with legal regulations.</li></ul> Lab Equipment <ul><li>Maintains, operates equipment and instruments supporting reference standard processing.</li><li>Provides general laboratory support such as routine instrument cleaning/preventative. maintenance, reference standard/sample receiving, chemical inventory, document filing and housekeeping.</li><li>Works with internal resources to maintain lab in an optimal state. 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></ul> Investigations <ul><li>Escalates any trends/events to the QC Lab Manager.</li><li>Escalates any reference standard documentation issues to the QC Lab Manager.</li><li>With guidance, participates in OOS/OOT/NOE and other investigations.</li><li>Assists, as and when needed, scientists working in the laboratory.</li><li>May assist in drafting, editing, and reviewing SOPs.</li></ul> Training <ul><li>Maintains assigned training records current and in-compliance.</li><li>May assist in the training of laboratory staff.</li></ul> Compliance <ul><li>Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting.</li><li>Documents accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.</li><li>Follows internal processes related to controlled substances.	continuous.</li></ul> Safety <ul><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>College graduate, preferably in a Science related field.</li><li>Laboratory experience related to sample management preferred.</li></ul> Knowledge <ul><li>Basic knowledge of reference standard/sample management in a laboratory environment.</li><li>Some knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS.</li><li>Competency in Microsoft Office Suite.</li><li>Proficiency with computers.</li></ul> Skills &amp; Abilities <ul><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></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.</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>Work independently on our client vacuum valves installation, troubleshooting, problem solving, maintenance and repairing on site/internal workshop.</li><li>Responds to customer calls; analyzes, and troubleshoots problems via phone, remote session or at customer site.&nbsp;&nbsp;</li><li>On time and correctly report working activities and time duration with customer signature.</li><li>Keep good communication with customers at various levels (tool engineers, section managers etc.)</li><li>Liaise with customers and internal stakeholders relating to technical and service issues.</li><li>Conducting customer support meetings and ensuring regular communication with customers.</li><li>Follow up and feedback customer complaints.</li><li>Follow up customer open issues until it closed.</li><li>Response for our client quality information collection and quality problem report.</li><li>Provide technical problem solving and roots cause analysis report.</li><li>Ability to support customer for urgent request in weekend and holiday.&nbsp;&nbsp;&nbsp;</li><li>Assessing customers’ needs and advice the customers with regards to spare parts, preventive maintenance and retrofit possibilities.</li><li>Special projects and other duties as assigned.&nbsp;&nbsp;&nbsp;</li></ul> Requirements: <ul><li>Mechanical or electronic background with college degree or above.</li><li>Minimum 3 years of service experience in Cleanroom environment (Semiconductor or vacuum industry is preferred).</li><li>Strong skill of diagnosing, repairing and troubleshooting.</li><li>Strong business acumen and ability to identify opportunities within problems.</li><li>Be able to work independently under pressure and irregular hours.</li><li>Personal accountability, team player.</li><li>Good communication and interpersonal skill.</li><li>Goal achievement.</li><li>Willing and able to travel frequently within short notice. Be adapted to irregular over time work together with customer urgent need.</li><li>Able and comfortable to communicate in English, Chinese. And 1 other additional language is a plus. (Japanese or Korean).</li></ul>

Responsibilities: <ul><li>Develop, implement, and optimize manufacturing processes to improve efficiency, quality, and cost-effectiveness.</li><li>Provide technical support for new product introduction (NPI), including process design, tooling, and equipment validation.</li><li>Conduct root cause analysis and lead corrective/preventive actions (CAPA) to&nbsp;</li><li>resolve production issues.</li><li>Collaborate with cross-functional teams (R&amp;D, Quality, Supply Chain, Maintenance) to ensure smooth project execution and production readiness.</li><li>Prepare and maintain process documentation, work instructions, and training materials.</li><li>Monitor key production metrics (yield, scrap, cycle time, downtime) and implement continuous improvement initiatives.</li><li>Participate in lean manufacturing, Six Sigma, and Kaizen activities to drive operational excellence.</li><li>Ensure compliance with safety standards, environmental regulations, and ISO/IATF quality system requirements.</li><li>Support cost reduction projects through process improvement, automation, and supplier collaboration.</li></ul> Requirements: <ul><li>Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or related field.</li><li>3–5 years of relevant experience in manufacturing engineering; automotive or electronics industry experience preferred.</li><li>Strong knowledge of manufacturing processes such as machining, assembly, injection molding, stamping, or PCB assembly (depending on industry).</li><li>Familiarity with APQP, PPAP, FMEA, Control Plan, and other quality tools.</li><li>Proficiency in CAD software (e.g., AutoCAD, SolidWorks, Creo) and MS Office.</li><li>Hands-on experience with Lean Manufacturing and problem-solving methodologies (5Why, 8D, DMAIC).</li><li>Good communication and coordination skills; able to work in cross-functional and multicultural teams.</li><li>English: able to read and write technical documents; spoken English is a plus.</li></ul>

Responsibilities: <ul><li>Perform evaluations and/or analyze unique problems that are new to equipment.</li><li>Perform predictive maintenance by analyzing routine failures and determining adjustments and repairs that need to be made.</li><li>Perform training as needed to Lower level Maintenance Techs on troubleshooting and repair techniques utilized with equipment</li><li>Perform specified preventative maintenance on production equipment to prevent equipment downtime.</li><li>Monitor equipment operations to ensure proper usage.</li><li>Construct and/or assemble new equipment</li><li>Troubleshoot equipment failures and repair as needed</li><li>Perform specified preventative maintenance on production equipment to prevent equipment down-time</li><li>Perform Lock Out / Tag Out requirements.</li><li>Work from blueprints, manuals, sketches and verbal instructions.</li><li>Help repairing on hydraulic, pneumatic and electromechanical systems.</li><li>Perform other duties as assigned or necessary to meet business conditions or changes.</li><li>Adheres to quality and safety systems or maintenance of quality and safety standards.</li></ul> Requirements: <ul><li>High school diploma or equivalent</li><li>5+ years experience in injection molding maintenance or extrusion, or mechanical, hydraulic, pneumatic and electrical repair</li></ul>

Responsibilities: <ul><li>Supervise and lead production team members across assigned shifts and production lines.</li><li>Ensure daily production schedules are met in compliance with safety, quality, and delivery requirements.</li><li>Monitor key performance indicators (OEE, yield, scrap, downtime) and implement corrective actions as needed.</li><li>Drive continuous improvement initiatives in productivity, cost reduction, and process efficiency.</li><li>Partner with Manufacturing Engineering, Quality, and Maintenance teams to resolve process and equipment issues.</li><li>Provide training, coaching, and performance feedback to team members to build skill and capability.</li><li>Enforce compliance with EHS standards, company policies, and 5S/lean manufacturing practices.</li><li>Ensure proper manpower planning, shift scheduling, and attendance management.</li><li>Manage production documentation, reporting, and escalation of issues to management.</li><li>Support new product introduction (NPI) and ensure smooth handover to mass production.</li></ul> Requirements:﻿ <ul><li>Bachelor’s degree/diploma in Manufacturing, Mechanical, Industrial Engineering, or related field.</li><li>Minimum 5–7 years of production experience in high-volume manufacturing, with at least 3+ years in a supervisory/lead role.</li><li>Strong knowledge of lean manufacturing principles, problem-solving, and root cause analysis.</li><li>Good understanding of ISO/IATF 16949, EHS, and quality management systems.</li><li>Proven leadership, people management, and conflict resolution skills.</li><li>Ability to work in a fast-paced, 24/7 manufacturing environment with flexibility to support multiple shifts.</li></ul>

Responsibilities: LMS Management:&nbsp; <ul><li>Assist with maintaining the Docebo LMS, including tasks such as workflow configuration, business rules, and permission management.</li></ul> Content Management: <ul><li>Upload and organize training materials and courses within the LMS. Ensure that all content is up-to-date, relevant, and consistent. Video editing.</li></ul> User Support:&nbsp; <ul><li>Provide technical support and troubleshooting assistance to internal teams. </li><li>Address and resolve any issues related to the LMS.</li></ul> Continuous Improvement:&nbsp; <ul><li>Assist with evolution of the platform and evaluation of new complementary solutions to add value for learners. </li><li>Examples include: adding multiple language support, closed captioning, and more.</li></ul> System Updates and Maintenance:&nbsp; <ul><li>Stay informed about updates and new features of Docebo and their impact on our learners. Update our configuration as needed based on platform upgrades.&nbsp;</li></ul> Use Case Expansion:&nbsp; <ul><li>Extend our current usage, which is focused on customer education, to internal training and employee on boarding, including integration with our HRIS.</li></ul> Reporting and Analytics:&nbsp; <ul><li>Generate and analyze reports on user behavior and overall system usage. Use data to make recommendations for improvements to affect user outcomes.</li></ul> Requirements: <ul><li>Bachelor’s degree in Education, Information Technology, a related field, or equivalent experience is required.</li><li>Prior 3+ years’ experience managing an LMS, preferably Docebo.</li><li>Strong technical and analytical skills to troubleshoot and resolve system and integration issues.</li><li>Experience with data integrations between systems (Workato, Docebo Connect, Webhooks, APIs, etc.).</li><li>Excellent organizational skills and attention to detail.</li><li>Analytical skills with experience in generating and interpreting reports and developing proposals for improvement.</li><li>Experience with video and audio editing.</li><li>Experience managing online training content.</li></ul>

Responsibilities: <ul><li>Perform preventive and corrective maintenance on sterile IV bag fillers, isolators, compounding equipment, sterilizers, component prep equipment, automated inspection machines, and secondary packaging systems.</li><li>Support equipment setup, calibration, and changeover in accordance with production schedules, maintenance plans, site SOPs, and cGMP requirements.</li><li>Assist in the installation, commissioning, and qualification of new sterile processing equipment, support equipment, and secondary packaging equipment.</li><li>Troubleshoot mechanical issues in real-time to minimize downtime while maintaining aseptic conditions and operator safety.</li><li>Ensure proper gowning, cleanliness, and contamination control practices when working in classified cleanroom environments.</li><li>Document all maintenance activities accurately in maintenance logs, work orders, and computerized maintenance management systems (CMMS).</li><li>Collaborate with Engineering, Manufacturing, and Quality to support equipment investigations, deviations, and continuous improvement initiatives.</li><li>Follow all safety procedures, including lockout/tagout, confined space, and PPE use; actively contribute to a culture of workplace safety and compliance.</li><li>Maintain spare parts inventory, tools, and maintenance supplies in an organized and audit-ready condition.</li><li>Participate in training and cross-functional activities to support plant startup and readiness for regulatory inspections.</li></ul> Requirements: <ul><li>High school diploma or technical certificate required, Associate’s degree in a mechanical or technical field preferred.</li><li>3+ years of experience as a mechanic or technician in a pharmaceutical, biotech, or sterile manufacturing environment.</li><li>Experience with isolator-based sterile filling equipment and cleanroom protocols is highly desirable.</li><li>Strong mechanical aptitude and experience with pumps, valves, conveyors, pneumatic systems, and packaging machinery.</li><li>Solid electrical and controls experience with automated systems, inspection machines, robotics, and camera systems highly preferred.</li><li>Working knowledge of cGMP, aseptic techniques, and safety regulations (OSHA, FDA, EU Annex 1).</li><li>Ability to read and interpret mechanical drawings, equipment manuals, and SOPs.</li><li>Familiarity with CMMS platforms and basic computer skills (e.g., Microsoft Office).</li><li>Self-motivated with strong attention to detail, problem-solving skills, and the ability to work independently or in a team.</li><li>Willingness to work flexible hours, including weekends or off-shifts during production or commissioning activities.</li></ul> Work Environment: <ul><li>Hands-on role in a cleanroom-based pharmaceutical manufacturing facility with strict safety and aseptic requirements.</li><li>Requires frequent gowning, standing, and work in confined or classified areas.</li><li>Fast-paced startup environment, requiring adaptability, initiative, and a collaborative mindset.</li><li>Occasional lifting of heavy tools or parts; use of ladders, lifts, and hand tools required.</li></ul>

Responsibilities: <ul><li>Perform preventive and corrective maintenance, troubleshooting, and repairs on facility infrastructure and critical utilities, including HVAC systems for cleanroom environment, compressed air and vacuum systems, clean utilities (WFI, purified water, clean steam), boilers, chillers, temperature control units, and effluent water treatment equipment.</li><li>Support equipment setup, calibration, qualification, and creation of maintenance plans of facility utilities and equipment.</li><li>Conduct round and inspection to monitor system performance and proactively address issues.</li><li>Ensure proper gowning, cleanliness, and contamination control practices when working in classified cleanroom environments.</li><li>Document all maintenance activities accurately in maintenance logs, work orders, and computerized maintenance management systems (CMMS).</li><li>Collaborate with Engineering, Manufacturing, and Quality to support equipment investigations, deviations, and continuous improvement initiatives.</li><li>Follow all safety procedures, including lockout/tagout, confined space, and PPE use; actively contribute to a culture of workplace safety and compliance.</li><li>Maintain spare parts inventory, tools, and maintenance supplies in an organized and audit-ready condition.</li><li>Participate in training and cross-functional activities to support plant startup and readiness for regulatory inspections.</li><li>Provide technical support of production activities during absence of production support team members or when bandwidth is insufficient.</li></ul> Requirements:﻿ <ul><li>High school diploma or technical certificate required, Associate’s degree in a mechanical or technical field preferred.</li><li>3+ years of experience as a mechanic or technician maintaining utilities or facilities infrastructure in a pharmaceutical, biotech, or regulated manufacturing environment.</li><li>Experience with pharmaceutical manufacturing equipment and cleanroom protocols is highly desirable.</li><li>Strong troubleshooting skills for mechanical, electrical, and control system issues.</li><li>Familiarity with building management systems (BMS) and alarm monitoring systems.</li><li>Solid electrical and controls experience with automated systems, inspection machines, robotics, and camera systems highly preferred.</li><li>Understanding of cGMP, contamination control, and safety regulations (OSHA, FDA, EU Annex 1).</li><li>Ability to read and interpret mechanical drawings, equipment manuals, and SOPs.</li><li>Familiarity with CMMS platforms and basic computer skills (e.g., Microsoft Office).</li><li>Self-motivated with strong attention to detail, problem-solving skills, and the ability to work independently or in a team.</li><li>Willingness to work flexible hours, including weekends or off-shifts during production or commissioning activities.</li></ul> Work Environment: <ul><li>Hands-on role in a regulated, sterile pharmaceutical manufacturing facility with strict safety and aseptic requirements.</li><li>Requires frequent gowning, standing, and work in confined or classified areas.</li><li>Fast-paced startup environment, requiring adaptability, initiative, and a collaborative mindset.</li><li>Occasional lifting of heavy tools or parts; use of ladders, lifts, and hand tools required.</li><li>Physical requirements include lifting climbing ladders, electrical troubleshooting, and working with hand and power tools</li></ul>

Role Description: <ul><li>The Facility Engineer will play a critical role in the greenfield design, construction, startup, and long-term operation of a state-of-the-art sterile injectable IV bag manufacturing facility. This role will lead the implementation and management of all facility infrastructure systems, including cleanrooms, HVAC, utilities, building automation, environmental monitoring, chemistry and microbiology lab systems, and energy management, ensuring full compliance with cGMP standards and regulatory expectations for sterile manufacturing.</li><li>The Facility Engineer will collaborate with cross-functional teams during construction, commissioning, qualification, and beyond, ensuring the facility infrastructure reliably supports sterile production, patient safety, and long-term business goals.</li></ul> Responsibilities: <ul><li>Lead the design review, specification development, and technical oversight of facility infrastructure systems including cleanrooms, HVAC, compressed air, chilled water, WFI, clean steam, and other critical utilities.</li><li>Develop and maintain facility engineering standards, equipment specifications, and technical documentation aligned to regulatory requirements and aseptic processing standards.</li><li>Oversee construction, installation, commissioning, and qualification of facility utilities and infrastructure systems, ensuring timely, compliant project execution.</li><li>Collaborate with Validation, Quality, and Operations teams to ensure proper facility qualification (IQ/OQ/PQ) and environmental monitoring readiness.</li><li>Promote and ensure adherence to safety protocols and safe work practices.</li><li>Perform risk assessments for engineering and maintenance activities.</li><li>Establish and manage preventative maintenance programs, calibration schedules, and facilities management SOPs to ensure optimal equipment performance and facility reliability.</li><li>Provide technical expertise in troubleshooting facility system deviations, non-conformances, and CAPAs, ensuring timely resolution and sustained compliance.</li><li>Partner with EHS, Operations, and Quality to ensure all facility systems meet safety, regulatory, and operational expectations.</li><li>Manage relationships with external engineering firms, contractors, and utility service providers to ensure effective delivery of construction and facility services. 11.	Support energy management, sustainability initiatives, and continuous improvement efforts to optimize facility operating costs and resource utilization.</li><li>Ensure ongoing regulatory inspection readiness and serve as SME for facility systems during audits and inspections.</li></ul> Requirements: Qualifications/Experience: <ul><li>Bachelor’s degree in mechanical, Electrical, Industrial, or Facilities Engineering.</li><li>3+ years of relevant experience in pharmaceutical or sterile manufacturing facility engineering.</li><li>Strong technical knowledge of facility infrastructure systems including HVAC for aseptic manufacturing, cleanrooms, and critical utilities.</li><li>Direct experience with greenfield facility construction, commissioning, and qualification highly desirable.</li><li>Solid understanding of FDA cGMP regulations, USP standards, and applicable environmental, health, and safety requirements.</li></ul> Skills/Competencies: <ul><li>Expertise Experience in facility system design, commissioning, and lifecycle maintenance.</li><li>Strong project management and contractor/vendor coordination capabilities.</li><li>Excellent problem-solving and root cause analysis skills.</li><li>Strong understanding of aseptic manufacturing facility requirements and environmental controls.</li><li>Effective communication and cross-functional collaboration skills.</li><li>High attention to detail, safety, and compliance.</li><li>Ability to thrive in a dynamic greenfield/startup environment.</li></ul>

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44 autonomous maintenance Jobs found

Manager – ADL GMP

Reference Standard Coordinator

Field Service Engineer

Manufacturing Engineer

Manufacturing Technician V (Senior Technician)

Supervisor III, Production

Learning Management Specialist

Process Mechanic – Sterile Filling & Packaging

Facility Mechanic

Facility Engineer

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Skills

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44 autonomous maintenance Jobs found

Manager – ADL GMP

Reference Standard Coordinator

Field Service Engineer

Manufacturing Engineer

Manufacturing Technician V (Senior Technician)

Supervisor III, Production

Learning Management Specialist

Process Mechanic – Sterile Filling & Packaging

Facility Mechanic

Facility Engineer

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

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TALENT

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Contact Us

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