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Process Validation Engineer II - Pharmaceutical - NH

Company: Michael Page
Location: Manchester
Posted on: May 6, 2021

Job Description:

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.SummaryExecute validation and qualification processes at multiple LSNE facilities. Work across teams to meet project deadlines and comply with all safety program requirements. Client DetailsOur latest client is a worldwide CDMO bringing life changing treatments and health solutions into the commercial market. They specialize in process development, aseptic fill finish and lyophilization, yielding high-quality small to medium size batches. Description

  • Technical knowledge of continuous process validation of processes in the cGMP manufacturing space in order to provide quality oversight to manufacturing operation of equipment/systems.
  • Carries out duties in compliance with all local, state, and federal regulations and guidelines including the FDA, EU. Complies with all client site policies and procedures.
  • Review and approval of executed documents and deviations for process validation activities and in support of process performance qualifications
  • Provide technical support on change controls, assessing new change controls for process equipment, automation systems that are proposed and all the requirements necessary to maintain a validated status
  • Generate and execute validation protocols (IQ, OQ and PPQ) for pharmaceutical drug manufacturing and laboratory equipment, including but not limited to HEPA filters, controlled temperature units, manufacturing equipment and packaging line equipment.
  • Characterize equipment operation processes and define critical process parameters and critical quality attributes
  • Write and execute the official test scripts, complete associated documentation for equipment and processes to ensure the test results are reported accuratelyProfile
    • Bachelor of Science degree in Chemical Engineering, Biochemistry, Biology or related scientific discipline required
    • Experience as Process Development Engineer or Validation engineer
    • Skilled in the development and execution of PPQ's. Review commissioning, qualification and validation related system life cycle documentation (user requirements, functional and design specifications, commissioning and qualification protocols).
    • Combination of equipment qualification, process validation, or cleaning validation is acceptable; QA pharmaceutical experience also preferred.
    • Validation experience with the following is highly preferred: Thermal characterization, Vacuum physics, Heat and mass transfer, Formulation, Aseptic Filling and Lyophilization, Steam Sterilization, data analysis and statistics.
    • Engagement and know how with regulatory inspections and knowledgeable in current industry standards and regulatory trends as they pertain to Validation of pharmaceutical or bio-pharmaceutical processes.
    • Job Offer
      • Competitive compensation and benefits package
      • 401(k) plan offers investment options and provides a company match
      • Basic life and accident insurance and a range of additional coverage offerings, including supplemental life insurance
      • Tuition assistance to help you build and improve your skills to advance your career with us
      • Comprehensive medical and prescription drug coverage in addition to dental and vision coverage
      • All employees accrue 5 weeks of vacation a yearJob Requirements:- Bachelor of Science Degree in bio/chemical engineering or related field, M.S., Ph.D., or M.B.A. preferred --- Experience with ultra-filtration, chromotography, large molecule, and drug product process development ---A minimum of three years industry experience in bioprocess development

Keywords: Michael Page, Manchester , Process Validation Engineer II - Pharmaceutical - NH, Engineering , Manchester, New Hampshire

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