- Legend Biotech USA, Inc. (Raritan, NJ)
- …of computer systems validation , equipment, utilities, and facility qualification, process validation , shipping validation , and data integrity.Key ... Responsibilities Provide quality and compliance oversight for computer systems validation , process validation , equipment, utilities, and facilities… more
- Katalyst HealthCares and Life Sciences (Franklin Lakes, NJ)
- …improvements. Requirements: Bachelors in chemical engineering. 5+ years of experience in process validation and development within the medical device, biotech, ... Responsibilities: Author and execute Master Validation Plans (MVPs), OQ (Operational Qualification), and PQ...Moulding and sizing of bioabsorbable components. Maintain and own Process FMEA (pFMEA) documentation and risk management files in… more
- Katalyst HealthCares and Life Sciences (West Mifflin, PA)
- …printers and prefer to use contractors to complete the 6-month project. The Senior Process Validation engineer will be in charge of procedure changes, ... the software pieces to the printers. 7-12+ Years of experience with Process Validation . Must have Experience with writing procedures. Must have Experience with… more
- Merck & Co. (Durham, NC)
- …preparation for commercial production.- The selected candidate will participate in equipment validation , process validation , and GMP laboratory readiness.- ... Specialist, Quality Control participates in a team of analysts in the development, validation , and routine testing for the BCG Product. The position will focus on… more
- Repligen (Rancho Dominguez, CA)
- …bioprocessing manufacturing systems. Lead projects in equipment design, tech transfer, process validation , and facility upgrades. Conceives, plans, and executes ... is highly desirable. Hands-on experience with: Tangential Flow Filtration (TFF) Process validation and equipment qualification Tech transfer between sites… more
- Insmed Incorporated (San Diego, CA)
- …material specifications, protocols and author development reports.Demonstrated experience with process validation and scale-down models for biopharmaceutical ... Medium Workplaces™ lists.OverviewWe are seeking a highly motivated expert in purification process development of viral vector gene therapy products. In this role you… more
- Global Channel Management Inc. (Pompano Beach, FL)
- About the job Process Validation /Manufacturing Eng Process Validation /Manufacturing Eng needs 1-3 years experience in a cGMP-regulated manufacturing ... or an equivalent combination of training and experience is required. Process Validation /Manufacturing Eng requires: Bachelor's degree in engineering or… more
- Merck & Co. (Rahway, NJ)
- …Innovation: Conduct laboratory-scale and manufacturing-scale studies to support commercial process validation and characterization. You'll design experiments, ... of biological molecules.Familiarity with late-stage process development, process characterization, process validation regulatory submissions,… more
- Merck & Co. (Rahway, NJ)
- …expected to apply their knowledge of product design and development, manufacturing process development, qualification, validation , and design control and risk ... deep knowledge in device design, requirement management, design verification, automation/ process development, design validation , human factors evaluations and… more
- Tris Pharma (Monmouth Junction, NJ)
- …Monmouth Junction, New Jersey, Tris has an immediate opening for a Method Validation R&D Senior Scientist ISummary:The Method Validation (MV) Research and ... guidance, performs analytical method validations and release/stability raw materials, in process (IP), finished products (FP) and stability (ST) samples for pilot… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …while liaising with other functions including but not limited to Tech Support, Process Improvement, Validation , Supply Chain, Operations, QA, Reg CMC, and IT. ... electronic batch record (EBR) updates and system improvements, support applicable process and facility updates, and support qualification activities associated with… more
- Merck & Co. (Rahway, NJ)
- …in design controls, risk analysis, control strategies, design verification testing, and process validation , with a strong understanding of quality management ... company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an… more
- Merck & Co. (Rahway, NJ)
- …experience to develop safe and robust manufacturing processes through process characterization, technology transfer, validation , filing and supply ... on their expertise to optimize and fully characterize the enzyme manufacturing process control strategy across different scales.The successful candidate will play a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …combined experience in commercial scale cGMP manufacturing, operations management, tech transfer, process and equipment validation or quality management; with a ... preference for Cell/Gene Therapy experienceMinimum of 5 years of experience of progressive leadership roles in a cGMP operation, with prior Biologics and/or cell therapy operations experience preferred.Prior experience leading large multilevel teams.A history… more
- Merck & Co. (Rahway, NJ)
- …engineering work process and deliverables (eg equipment fabrication, FAT, SAT, Validation etc.)Must be innovative and drive new ideas, but also have pragmatic ... decisions standpoint.Experience in equipment Fabrication, FAT/SAT, start-up, qualification and/or validation is preferredFill/finish process scale-up, Drug Delivery… more
- US Bank (Atlanta, GA)
- …implementation process , as well as model usage and performance. The validation process also identifies corrective actions to ensure timely remediation of ... liquidity, market, operational, reputational, strategic, and other risks as appropriate. Validation Analysts within MRM provide independent validation of models… more
- Katalyst HealthCares and Life Sciences (Richmond, VA)
- …ensuring they meet regulatory standards and company policies. Identify and implement process validation (PV) strategies to enhance efficiency, quality, and ... including FDA 21 CFR Part 820, GMP, and ISO 13485. Experience in process validation (PV), equipment qualification (IQ, OQ, PQ), and software validation .… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …representative for contractor services including design, fabrication, installation, and validation Point person for process improvement activities, including ... to: Lead Engineer, Manufacturing Engineering (Supervisor) Essential Functions Leads process and equipment troubleshooting to support deviations, corrective actions… more
- Eisai, Inc (Exton, PA)
- …discretion.9. Interact cross-functionally with Support Services, Facilities, Biologics Process Development, Quality Assurance, Quality Control, Validation , ... purification, biologics equipment operation, and CIP/SIP operations. Knowledgeable in process development, technology transfer, equipment scale-up, equipment validation… more
- RCM Life Sciences and IT (Norwood, MA)
- …in support of Quality and Engineering for equipment qualification, new product development, process validation and test method validation . The successful ... Contract Title: Validation Engineer Compensation: $65/Hr. Location: Southwest of Boston...Responsibilities: Collaborate with Engineering and Quality on equipment / process changes, additions and installs for how to qualify… more
