Production Technician I

Senior Business Intelligence Analyst

Compounding Technician

Filling Technician

Equipment Engr - Automation and PLC

Manufacturing Engineer II - CCD Support

Senior Project Management Engineer

QC Lab Sample Coordinator

Environmental Health and Safety (EHS) Manager

Senior Microbiology Technician

Responsibilities: <ul><li>Operate, monitor, and adjust sterile manufacturing equipment used for formulation, filling, and packaging of IV bag products in compliance with cGMP and SOPs.</li><li>Perform routine preventive maintenance on production equipment to ensure operational readiness and minimize downtime.</li><li>Support equipment and process qualifications, including execution assistance, documentation support, and adherence to qualification protocols.</li><li>Act as first-line troubleshooting support for mechanical or operational equipment issues, escalating to Engineering or Maintenance as required.</li><li>Assist with isolator technology operations, including cleaning, sterilization, and environmental control procedures.</li><li>Participate in line clearance, changeover, and cleaning activities to maintain continuous production operations.</li><li>Accurately complete batch records, logbooks, and production documentation in compliance with data integrity and cGMP requirements.</li><li>Collaborate with Quality Assurance during in-process checks, deviation investigations, and CAPA activities.</li><li>Adhere to DEA and site procedures for controlled substance handling, including documentation and security protocols.</li><li>Contribute to continuous improvement initiatives focused on safety, efficiency, and product quality.</li><li>Work closely with cross-functional teams, including Engineering, Validation, and Quality, to support operational readiness.</li><li>Comply with all Environmental Health &amp; Safety (EHS) standards and maintain a clean and safe work environment.</li></ul> Key Stakeholders Internal <ul><li>Production Supervisor and Production Manager</li><li>Engineering and Maintenance</li><li>Validation and Quality Assurance</li><li>Materials and Warehouse Teams</li><li>Environmental Health &amp; Safety (EHS)</li></ul> External <ul><li>Equipment vendors and service technicians (as required)</li></ul> Requirements: Qualifications &amp; Experience <ul><li>High school diploma or equivalent required; Associate degree or technical certification in mechanical, engineering, or life sciences preferred.</li><li>Minimum 2 years of experience in pharmaceutical or other regulated manufacturing environments, including compounding, filling, inspection, or secondary packaging.</li><li>Prior experience with sterile products or IV bag manufacturing strongly preferred.</li><li>Strong mechanical aptitude with the ability to perform routine maintenance and troubleshoot equipment issues.</li><li>Experience operating automated production equipment using HMI or SCADA interfaces required.</li><li>Working knowledge of cGMP, aseptic processing, and controlled substance regulations preferred.</li><li>Ability to read, understand, and follow SOPs, maintenance procedures, and qualification protocols.</li></ul> Skills &amp; Competencies <ul><li>Strong technical and mechanical problem-solving skills</li><li>High attention to detail with a commitment to quality and data integrity</li><li>Ability to work effectively in a fast-paced, highly regulated environment</li><li>Strong verbal and written communication skills</li><li>Team-oriented mindset with a collaborative approach</li><li>Comfortable working in cleanroom environments with PPE requirements</li></ul>

Role Description: <ul><li>The Continuous Improvement EMIA team reports to Operations Automotive EMIA.</li><li>By providing new generation digital solutions to our Operational teams across EMIA, our team creates full transparency and speed in the ongoing digital &amp; lean transformation(s), which will enable all involved functions to leverage data to develop business insights and roadmap updates based upon clearly arranged and understandable data. Due to the extended scope, focusing also on the connecting processes from Supplier(s) to Manufacturing ending at the Customer(s) (internal and external) we will function as ‘the’ differentiator for our Company.</li><li>The Data Scientist Automotive EMIA will report to the Smart Factory Leader Automotive EMIA.&nbsp;</li></ul> Responsibilities:&nbsp; <ul><li>Lead projects and work together with our Automotive EMIA Operations plants, internal (IT, , Corporate Technology, CoE, SC, ..) and external partners in the area of Smart Factory (Applications, ML, AI, DL), aligned with Operations Automotive EMIA Strategy.</li><li>Lead Smart Factory improvement projects (Enhancements) of existing applications together with internal / external supplier and customers (project management) until the level of RTD (Ready To Deploy)</li><li>·Use a combined knowledge of computer science and applications, modelling, statistics, analytics and maths to solve problems.</li><li>Identify and interpret data sources, manage large amounts of data, merge data sources together, ensure consistency of datasets, create visualizations to aid in understanding data.</li><li>Develop, Validate and Deploy (including Training and Coaching of the users) until the level of RTD (Ready To Deploy), Digital Factory Applications, ML models, contributing to waste elimination and efficiency improvements within all Operations functions (Manufacturing, Quality, SC, LOG, ….), this together with our internal and external partners.</li></ul>&nbsp;Requirements: Desired candidate &amp; Qualification <ul><li>Good understanding of a technology driven manufacturing company.</li><li>Knowledge of the core manufacturing technologies: Stamping, Plating, Assembly, Molding.</li><li>Experienced with data visualization tools like PowerBi, Tableau, ThingWorx,..</li><li>Good applied statistics skills, such as distributions, statistical testing, regression, etc.</li><li>Development experience in programming languages R, Python.</li><li>Knowledge, experience in JAVA scripting</li><li>Excellent pattern recognition and predictive modelling skills.</li><li>Excellent understanding of machine learning techniques and algorithms, such as k-NN, Naive Bayes, SVM, Decision Forests, neural networks and deep learning etc.</li><li>Experience in technologies like, Jupyter Notebooks, Numpy, Pandas, Seaborn, Scikit-learn, PyTorch and TensorFlow.</li><li>Exposure to recent developments in Deep Learning, Gen AI, Agentic AI domain.</li><li>Database skills, on-premises and cloud based.</li><li>Experience in AWS is an advantage, functional knowledge of AWS platforms such as Sagemaker, S3, and RedShift.</li><li>Excellent presentation skills in both spoken en written English.</li><li>&nbsp;Excellent and strong communicator</li><li>The ability to translate, explain and bring, complex data science topics to an easy understandable level, speeding up acceptance level in general.</li><li>Bachelor or master’s in data science</li><li>Team player with a solution focused problem-solving mentality.</li><li>Change agent with high Execution level, including training and coaching talents.</li><li>Passioned about the combination of Technology, Data, Analytics and Statistics with link to Quality, Product and Process Engineering</li><li>Inspired by and searching actively for new technologies and methods.</li></ul>

Responsibilities: <ul><li>Operate, monitor, and adjust sterile manufacturing equipment for formulation, filling, and packaging of IV bag products in compliance with SOPs, cGMP, and safety requirements.</li><li>Perform routine preventive maintenance and minor repairs on production equipment to maintain optimal operating conditions.</li><li>Serve as first-line troubleshooting support for equipment and process issues, escalating to engineering or maintenance as required.</li><li>Support equipment and process qualifications, including protocol review, execution participation, and documentation completion.</li><li>Assist in the creation, revision, and implementation of SOPs and production-related procedures.</li><li>Provide training, guidance, and on-the-job support to Production Technician I personnel.</li><li>Perform cleaning, changeover, and line clearance activities to maintain manufacturing operations.</li><li>Accurately complete batch records, logbooks, and production documentation in compliance with data integrity requirements and cGMP practices.</li><li>Review documentation completed by fellow members of the production team.</li><li>Collaborate with Quality Assurance during in-process checks, deviation investigations, and CAPA activities.</li><li>Adhere to DEA and site procedures for controlled substance handling, including documentation and security protocols.</li><li>Work closely with cross-functional teams including Engineering, Validation, and Quality to support operational readiness.</li><li>Operate isolator technology, including performing and verifying sanitization steps, and supporting advanced troubleshooting.</li><li>Ensure controlled substances are handled, documented, and stored per DEA and site requirements.</li><li>Participate in continuous improvement and lean manufacturing initiatives to enhance safety, quality, and efficiency.</li></ul> Requirements: Qualifications / Experience <ul><li>High school diploma or equivalent required; associate degree or technical certification in a mechanical, engineering, or life sciences discipline preferred.</li><li>Minimum of 5 years’ experience in pharmaceutical or regulated manufacturing in areas of compounding, filling, inspection, and secondary packaging. Experience with sterile products or IV bag production preferred.</li><li>Demonstrated mechanical aptitude with hands-on equipment troubleshooting and maintenance skills.</li><li>Knowledge of cGMP, aseptic processing, and controlled substance handling requirements.</li><li>Minimum of 3 years’ experience working with automated production equipment utilizing HMI or SCADA interface required.</li><li>Experience with isolator-based manufacturing strongly preferred.</li><li>Experience reading and following technical documents such as SOPs, maintenance procedures, electrical drawings, equipment arrangements, piping diagrams, and qualification protocols</li></ul> Skills / Competencies <ul><li>Demonstrated problem-solving and mechanical troubleshooting skills.</li><li>Ability to mentor and train less experienced technicians.</li><li>Excellent attention to detail and documentation accuracy.</li><li>Effective communication and teamwork skills.</li><li>Commitment to safety, quality, and data integrity.</li><li>At home working in cleanroom environments with PPE requirements.</li></ul>

Responsibilities: <ul><li>Operate, monitor, and adjust sterile manufacturing equipment for formulation, filling, and packaging of IV bag products in compliance with SOPs, cGMP, and safety requirements.</li><li>Perform routine preventive maintenance and minor repairs on production equipment to maintain optimal operating conditions.</li><li>Serve as first-line troubleshooting support for equipment and process issues, escalating to engineering or maintenance as required.</li><li>Support equipment and process qualifications, including protocol review, execution participation, and documentation completion.</li><li>Assist in the creation, revision, and implementation of SOPs and production-related procedures.</li><li>Provide training, guidance, and on-the-job support to Production Technician I personnel.</li><li>Perform cleaning, changeover, and line clearance activities to maintain manufacturing operations.</li><li>Accurately complete batch records, logbooks, and production documentation in compliance with data integrity requirements and cGMP practices.</li><li>Review documentation completed by fellow members of the production team.</li><li>Collaborate with Quality Assurance during in-process checks, deviation investigations, and CAPA activities.</li><li>Adhere to DEA and site procedures for controlled substance handling, including documentation and security protocols.</li><li>Work closely with cross-functional teams including Engineering, Validation, and Quality to support operational readiness.</li><li>Operate isolator technology, including performing and verifying sanitization steps, and supporting advanced troubleshooting.</li><li>Ensure controlled substances are handled, documented, and stored per DEA and site requirements.</li><li>Participate in continuous improvement and lean manufacturing initiatives to enhance safety, quality, and efficiency.</li></ul> Requirements: Qualifications / Experience&nbsp; <ul><li>High school diploma or equivalent required; associate degree or technical certification in a mechanical, engineering, or life sciences discipline preferred.</li><li>Minimum of 5 years’ experience in pharmaceutical or regulated manufacturing in areas of compounding, filling, inspection, and secondary packaging. Experience with sterile products or IV bag production preferred.</li><li>Demonstrated mechanical aptitude with hands-on equipment troubleshooting and maintenance skills.</li><li>Knowledge of cGMP, aseptic processing, and controlled substance handling requirements.</li><li>Minimum of 3 years’ experience working with automated production equipment utilizing HMI or SCADA interface required.</li><li>Experience with isolator-based manufacturing strongly preferred.</li><li>Experience reading and following technical documents such as SOPs, maintenance procedures, electrical drawings, equipment arrangements, piping diagrams, and qualification protocols</li></ul> Skills/Competencies <ul><li>Demonstrated problem-solving and mechanical troubleshooting skills.</li><li>Ability to mentor and train less experienced technicians.</li><li>Excellent attention to detail and documentation accuracy.</li><li>Effective communication and teamwork skills.</li><li>Commitment to safety, quality, and data integrity.</li><li>At home working in cleanroom environments with PPE requirements.</li></ul>

Overview: <ul><li>The Equipment Engr - Automation and PLC is responsible for ensuring the reliable performance of production equipment by developing, modifying, and troubleshooting PLC programs and CCD (vision) systems.&nbsp;</li><li>The role supports day-to-day plant operations through automation debugging, sequencing improvements, and real-time issue resolution to enhance productivity and OEE.&nbsp;</li><li>This position leads technical training for technicians and new team members, documents system updates, and contributes to continuous improvement initiatives, including deployment and ISO compliance.&nbsp;</li><li>The engineer serves as a key resource in maintaining stable, efficient, and high-quality automated manufacturing processes.</li></ul> Responsibilities: <ul><li>Trouble shooting, Modify or Create Machine PLC program to suit the need of the plant.</li><li>Responsibel for repair and maintenance of the CCD System of the production line.</li><li>PLC system of the automation debugging and improve the sequencing.</li><li>Suggest improvement of automation PLC program to improve productivity and OEE.</li><li>Train technician to resolve the issues encountered between the production.</li><li>CCD light adjustments to improve the performance.</li><li>Responsible to resolve all issues encounter during production run.&nbsp;</li><li>Support on resolving CCD issues encounter during production run and documenting.&nbsp;&nbsp;</li><li>Impart trainings and development for new joiners, Technical Trainees etc.</li><li>Review of deployment</li><li>Review ISO documents and update, Engage in ISO audits.</li></ul> Requirements:&nbsp; <ul><li>Bachelor in Major in Electrical/Electronics</li><li>Preferably Mechanical, Electrical/Electronics and Industrial Engineer,</li><li>5 years minimum experience in the automation assembly and Tooling Design &amp; Development</li></ul> Knowledgeable on this different type of Programming Languages: <ul><li>Ladder Logic</li><li>Function block diagrams</li><li>Structured text</li><li>Sequential flow charts</li><li>Instruction List</li></ul>

Overview: <ul><li>Design and developed electrical control system,testing and qualification introduce advanced electrical control technology with the objective of ensuring new assembly equipment meets schedule and requirements from customers and ECO within the direction of department manager and staff manufacturing engineer.&nbsp;</li><li>Manage and trouble shooting of CCD and cost saving within direction of policies.</li></ul> Responsibilities: <ul><li>Trouble shooting, Modify or Create Machine PLC program to suit the need of the plant.</li><li>Responsible for repair and maintenance of the CCD System of the production line.</li><li>PLC system of the automation debugging and improve the sequencing.</li><li>Suggest improvement of automation PLC program to improve productivity and OEE.</li><li>Train technician to resolve the issues encountered between the production.</li><li>CCD light adjustments to improve the performance.</li><li>Responsible to resolve all issues encounter during production run.&nbsp;</li><li>Support on resolving CCD issues encounter during production run and documenting.&nbsp;&nbsp;</li><li>Impart trainings and development for new joiners, Technical Trainees etc.</li><li>Review of deployment</li><li>Review ISO documents and update, Engage in ISO audits.</li></ul> Requirements:&nbsp; <ul><li>Bachelor in Major in Electrical/Electronics</li><li>5+ years’ experience and practitioner in the automation assembly and Tooling Design &amp; Development</li><li>Computer Knowledge, MS Office etc, SAP knowledge added advantage</li><li>Integrity, Accountability, innovation, Communication.&nbsp;</li><li>Strong background in PLC programming: capable of programming, debugging, editing, and creating new PLC logic.&nbsp;</li><li>Familiar with CCD (Charge-Coupled Device) cameras, especially those used in automated measurement systems (e.g., Autoline).&nbsp;</li><li>Experience with vision system programming tools such as Visco, Keyence, and Datalogic.&nbsp;</li><li>Solid programming skills required; CCD-specific knowledge can be trained.&nbsp;</li><li class="ql-align-justify">Willingness to work on Saturdays when needed</li></ul>

Responsibilities: Project Timeline: <ul><li>Identify and align projects goals and scope with PJM and PM, and breakdown tasks of tooling/process developments and qualification</li><li>Make/align tooling development and qualification timeline, assign tasks to Ops team include tooling development, materials purchase</li><li>Track and manage core team to execute project progress based on committed project schedule</li></ul> Project Cost: <ul><li>Lead Ops to simulate sample cost and production cost to achieve project landing zone target, lead Ops to optimize launch cost to the best</li><li>Budget and control scrap cost though leverage design and manufacturing process to meet project target during NPI phase</li></ul> Project Execution: <ul><li>Guide capacity planning, materials sourcing and manpower to support all builds in the plant.</li><li>Oversee the progression of tooling/process development, identify bottleneck and issues, organize Ops team to improve those bottleneck and issues.</li><li>Oversee risks assessment in project execution, stay interlock with PJM to make multigation plan and conduct the planned activities in Ops.</li><li>Finalize the Safe Launch plan for the appropriate mix of product, tool capability and demand with the approval of the PjM, Quality, MDPE, and PjE. a. Lead Safe Launch team meetings to assure successful HVM startup and manufacturing process qualification for attainment of required metrics for successful G5 handoff.</li><li>Align the budget with Ops team with the tooling list provided by MPDE-A, control total capital spending against CER.</li><li>Lead and coordinate line setup to conduct LVM sample builds and coordinate HVM tool builds.</li><li>Lead Ops to make ramp up plan, include materials, operations and tool capacity ramp up, ensure manufacture team take over production control smoothly after G5.</li></ul> Product Sustaining: <ul><li>Product migration, as a receiving or sending leader to execute product move in or move out, including project timeline, investment, cost control, machine/material/manpower preparation, safety stock, safe launch, etc.</li><li>Lead product capacity analysis and expand it through re-investment per estimation.</li></ul> Requirements: <ul><li>Bachelor degree, engineering background is better</li><li>PMP certification preferred</li><li>At least 5 years related working experience in project management, 1~2 years experience in connector/cable/cable assembly is better</li></ul>

Responsibilities: Sample Management <ul><li>Performs QC sample/reference standard/chromatographic column receipt, processing, distribution for testing and storage.</li><li>Performs QC sample reconciliation and disposal.</li><li>Tracks inventory of product samples, stability samples, and test materials in the lab.</li><li>Uses laboratory software for sample, reference standard, chromatographic column management.</li><li>Verifies accuracy of labeling/documentation provided with samples.</li><li>Informs QC Coordinator if chemical or reference standard is expired for removal from laboratory area.</li><li>Send samples for outside testing. Submit samples to the appropriate labs 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 laboratory supplies.</li><li>Provide status updates to QC management and other departments regarding the submission of samples.</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 sample processing.</li><li>Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, 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&nbsp; <ul><li>Escalates any trends/events to the QC Lab Manager.</li><li>Escalates any sample and 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&nbsp; <ul><li>Performs assigned work in a timely and safe manner conforming to regulatory, company and compendia 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.</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 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 computer savvy.</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.</li><li>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>

Responsibilites: <ul><li>Develop and implement site-wide EHS programs aligned with federal, state, and local regulations, including OSHA, EPA, and DEA requirements for controlled substances.</li><li>Lead risk assessments, job hazard analyses (JHAs), and containment evaluations, particularly in areas handling high-potent and controlled substances.</li><li>Serve as the primary liaison for EHS-related aspects of DEA compliance, supporting controlled substance handling protocols in collaboration with Quality, Security, and Operations.</li><li>Oversee the environmental and safety controls for controlled substances, ensuring proper ventilation, storage, access restrictions, spill response, and waste disposal procedures in compliance with DEA and EPA regulations.</li><li>Develop and maintain physical and procedural controls related to controlled substance areas (e.g., vaults, restricted labs, destruction processes) in partnership with Security and Regulatory Affairs.</li><li>Lead the investigation and root cause analysis of all incidents, near-misses, and controlled substance discrepancies, and implement corrective/preventive actions.</li><li>Ensure training and education of site personnel in EHS best practices, with a focus on potent compound safety, exposure monitoring, and controlled substance handling protocols.</li><li>Implement industrial hygiene programs, including monitoring of airborne concentrations and potential operator exposure to potent and hazardous compounds.</li><li>Establish robust programs for emergency preparedness, including chemical spills, fires, security threats, and controlled substance incidents.</li><li>Maintain all required permits, records, and documentation related to hazardous waste, emissions, safety incidents, and controlled substance EHS compliance.</li><li>Partner with Engineering, Validation, and Operations to incorporate EHS and security standards into facility, utility, and equipment design and commissioning.</li><li>Foster a strong culture of safety, accountability, and environmental stewardship at all levels of the organization.</li></ul> Requirements: <ul><li>Bachelor’s degree in Environmental Science, Occupational Health &amp; Safety, Chemical Engineering, or related field (Master’s preferred).</li><li>Minimum of 7–10 years of progressive EHS experience in a GMP-regulated pharmaceutical or biotechnology manufacturing environment.</li><li>Direct experience managing EHS compliance for controlled substances (DEA Schedules II–V) and high-potency APIs strongly preferred.</li><li>In-depth knowledge of OSHA, EPA, DEA, NJDEP, and global EHS regulations and guidelines.</li><li>Familiarity with industrial hygiene, containment technologies, and safe handling procedures for potent compounds</li><li>Experience leading EHS activities during greenfield/startup site development and qualification is a plus.</li></ul>

Responsibilities: <ul><li>Perform and oversee complex microbiological activities, including environmental monitoring (viable and non-viable), utility sampling (e.g., water, compressed gases), and aseptic process support in areas utilizing isolator technology.</li><li>Conduct and review microbiological testing for bioburden, endotoxin (LAL), sterility, and microbial identification on raw materials, in-process samples, and final products.</li><li>Support and lead aspects of aseptic process simulations (media fills) including planning, execution, incubation, and interpretation of results within isolator systems.</li><li>Assist in the startup and qualification of the microbiology laboratory including equipment qualification, SOP development, method verification/validation, and environmental monitoring qualification.</li><li>Contribute to investigations, non-conformances, and microbiological excursions by providing subject matter expertise and supporting root cause analysis and CAPA implementation.</li><li>Ensure accurate and timely documentation of laboratory data in compliance with data integrity principles and cGMP guidelines.</li><li>Mentor and provide technical guidance to junior microbiology staff, fostering a culture of scientific excellence, compliance, and continuous learning.</li><li>Maintain laboratory readiness for internal and external audits by following and enforcing good laboratory practices and cGMP expectations.</li><li>Participate in ongoing improvements to laboratory procedures, contamination control strategies, and sterility assurance programs.</li><li>Interface cross-functionally with Quality Assurance, Manufacturing, Validation, and Engineering to support cleanroom and equipment qualifications, isolator decontamination cycles, and site expansion activities.</li></ul> Requirements: Qualifications/Experience: <ul><li>Bachelor’s degree in microbiology, Biology, Life Sciences, or a related field.</li><li>Minimum of 3-5 years of microbiology laboratory experience in a cGMP pharmaceutical or biotechnology manufacturing environment.</li><li>Experience with isolator-based sterile manufacturing processes and aseptic support activities is strongly preferred.</li><li>Working knowledge of cGMPs, FDA and EU Annex 1 requirements, and microbiological standards (USP &lt;61&gt;, &lt;62&gt;, &lt;71&gt;, &lt;85&gt;, &lt;1116&gt;).</li><li>Experience supporting laboratory equipment startup, qualification, and routine maintenance preferred.</li><li>Prior experience with high potent APIs and/or controlled substances is desirable.</li></ul> Skills/Competencies: <ul><li>Advanced technical skills in environmental monitoring, microbial testing, and aseptic processing support.</li><li>Strong documentation and data integrity skills with a meticulous attention to detail.</li><li>Demonstrated ability to troubleshoot microbiological and laboratory equipment issues.</li><li>Effective time management and prioritization skills in a fast-paced environment.</li><li>Strong communication skills with the ability to train and mentor junior staff.</li><li>Proactive, collaborative, and compliance-oriented mindset.</li><li>Comfortable working in cleanroom environments and adhering to gowning and contamination control protocols.</li></ul>

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38 cnc controlled grinding machine Jobs found

Production Technician I

Senior Business Intelligence Analyst

Compounding Technician

Filling Technician

Equipment Engr - Automation and PLC

Manufacturing Engineer II - CCD Support

Senior Project Management Engineer

QC Lab Sample Coordinator

Environmental Health and Safety (EHS) Manager

Senior Microbiology Technician

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38 cnc controlled grinding machine Jobs found

Production Technician I

Senior Business Intelligence Analyst

Compounding Technician

Filling Technician

Equipment Engr - Automation and PLC

Manufacturing Engineer II - CCD Support

Senior Project Management Engineer

QC Lab Sample Coordinator

Environmental Health and Safety (EHS) Manager

Senior Microbiology Technician

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

EMPLOYER

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