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Process Validation Engineer

Company: Affinivax
Location: Cambridge
Posted on: November 25, 2022

Job Description:

About AffinivaxAffinivax is a Cambridge-based clinical-stage biotechnology company with a novel, next-generation approach to the development of vaccines and immunotherapies targeting infectious and other immune-mediated diseases. This novel and highly efficient vaccine technology - called Multiple Antigen Presenting System (MAPS) - enables the high-affinity binding of protective polysaccharides as well as proteins in a single vaccine, uniquely inducing a broad and protective B-cell and T-cell immune response.

Our vision is to take a major step forward in vaccine innovation to prevent and combat a wide range of infectious and other immune-mediated diseases, protecting infants and adults in our communities and making a meaningful impact on global public health. Affinivax is focused on developing vaccines for the most challenging bacterial infections, with a goal of improving upon existing vaccines and providing solutions for where there are no vaccines or prevention strategies available today.The role...This position will be responsible for execution of Process Validation (PV) studies to test and verify process robustness. This role will include providing support to routine process validation studies, assisting with new product technology transfers or lifecycle management changes, and audit support. Candidates will have a demonstrated aptitude for learning new systems and software, performing data analysis, and applying statistical methods, learning new manufacturing processes. Ability to communicate effectively across multiple platforms/mediums and skill with technical writing is essential.You will have the opportunity to...

  • Scope includes but not limited to PVMP Generation, PPQ Protocols, Resin Lifetime, UF Membrane Lifetime, Mixing Validation, Bioburden/Endotoxin Control, Media Pre-Filtration, Impurity Clearance, Intermediate Process Hold, Reprocessing, BPC Hold Studies.
  • Review commissioning, qualification, and validation related system lifecycle documentation (user requirements, functional and design specifications, commissioning, and qualification protocols).
  • Author Process qualification/ verification validation plans; this includes the development of process requirements and specifications drafts to execute process performance qualifications.
  • Compile trace matrices, perform data analysis, draft validation protocol discrepancy reports
  • Author process validation summary reports
  • Author and perform the technical review of deviations, change controls, perform process monitoring (manufacturing data summary and analysis, data presentation), perform activities for lot release (assess deviations and process changes)
  • Perform risk assessment and mitigation steps to achieve validation requirements and ensure each process remains in a validated state of compliance by compiling and analyzing data for continued process verification.
  • Maintain and perform calibration on all validation test equipment and processes.
  • Owner to implement CAPA with minimal oversight to achieve quality, timely results
  • Participate in Regulatory Audits.
  • Work closely with other validation department personnel and cross-functionally with MSAT, Manufacturing, Engineering, QA, QC, Regulatory and project management to achieve all project deliverables.
  • Coordinate and execute validation protocol activities with consistent and effective communication with other functions.
  • Perform other duties as assignedWho you are and what you bring to the team...
    • Bachelor of Science Degree in Chemical Engineering, Biotechnology, Biochemistry are preferred. Other life science degrees are acceptable
    • 4+ years of biologics/vaccines industry experience in Process Validation, MSAT, Engineering or Manufacturing.
    • Familiarity with commercial manufacturing and cGMP
    • Possess strong knowledge of Process Performance Qualification /Validation practices, including applicable regulations.
    • Basic knowledge of statistical software is preferred
    • Proficiency with Word, PowerPoint, and Excel is expected.
    • Good communication, organizational and interpersonal skills
    • Able to perform elementary data analysis e.g. simple graphing, charting, predefined calculations, e.g. mean, std. deviation, SPEW, MAD.
    • Technical writing skills are critical. The ability to write technical documentations clearly and concisely is an absolute requirement. This position will define and execute methods of process validation which will be scrutinized by regulatory bodies and customers.
    • Work in a highly independent fashion with minimal guidanceWhat We Offer:
      • Competitive compensation
      • Medical and Dental plans (BCBS), employer-paid at 85%
      • Vision Insurance, employer-paid at 100%
      • Life Insurance, Short- and Long-Term Disability
      • Flexible Spending Accounts/Health Savings Accounts
      • Wellness Benefits
      • 401(k) Plan with a 4% match
      • Tuition Reimbursement
      • Generous PTO package
      • 11 paid holidays, plus Holiday Shutdown
      • Pet Insurance
      • Subsidized Parking
      • Commuter Reimbursement Program
      • Brand new facility in Kendall SquarePlease Note:
        In accordance with Affinivax's duty to provide and maintain a safe workplace that is free of known hazards, we have adopted a COVID-19 vaccine policy to protect the health of our employees and their families, our visitors, and the community at large from COVID-19. This policy requires all employees, contractors, and temporary workers, to (1) obtain an approved vaccination and provide proof of vaccination or (2) request an accommodation for a medical or religious exemption. Our policy is based on guidance from the Centers for Disease Control (CDC) and Prevention.Affinivax is committed to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, national origin, age, disability, genetic information, status as a veteran or as a member of the military or status in any group protected by applicable federal or state laws.Agencies:
        All resumes submitted by search firms/employment agencies to any employee at Affinivax via email, the internet, or in any form and/or method will be deemed the sole property of Affinivax, unless such search firms/employment agencies were engaged by Affinivax for this position and a valid agreement with Affinivax is in place. In the event a candidate who was submitted outside of the Affinivax agency engagement process is hired, no fee or payment of any kind will be paid.

Keywords: Affinivax, Cambridge , Process Validation Engineer, Other , Cambridge, Massachusetts

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