Validation & Engineering Group
ATL02-052225_ Biotech CQV Engineer/Specialist (MA)
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Job Description
- Req#: 3417694
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Author, review, and execute protocols (IOQ, PQ) for automated drug product systems, including:
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Aseptic vial and syringe filling lines
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Integrated isolators
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Cappers, crimpers, denesters, and tub debaggers
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Visual inspection lines (manual, semi-automated, and automated)
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Primary and secondary packaging lines (labelers, cartoners, checkweighers, case packers)
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Lead equipment walkdowns, protocol execution, and deviation management.
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Interface with Quality, MS&T, and Operations to support schedule adherence and resolution of issues.
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Support qualification of new components and cleaning cycles associated with isolators and autoclaves.
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Bachelor’s degree in science, engineering, or related field.
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Minimum 5 years of CQV experience with fill/finish and packaging systems in sterile or biotech manufacturing environments.
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Strong knowledge of isolator technology, visual inspection, and packaging equipment qualification.
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Familiarity with PQs for filling systems and media fill qualification support is preferred.
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Excellent communication and documentation skills.
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Ability to work independently and collaboratively across functions.
Validation & Engineering Group, Inc. (V&EG) is a leading services supplier providing solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the areas of Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other technical services.
We are currently seeking a CQV Engineer with expertise in fill/finish and packaging systems to support commissioning and qualification for new GMP production and packaging areas. The selected candidate must be available to work in production, packaging, and construction areas, complying with safety and gowning requirements.
Location: Norwood, MA
Responsibilities:
Qualifications:
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About the company
Validation & Engineering Group provides world-class service and expertise to the pharmaceutical, medical device and biotechnology industries. We offer our clients: Validation, Control System Solutions, Instrumentation, Training, Equipment Rentals, and Regulatory Compliance Services to ensure adherence to Federal and European regulatory agencies. Our group had serve in solid dosages, liquids, creams, lyophilizers, and parenteral dosage.
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