AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit



AGC Biologics team is looking for an Sr./Principal MSAT Engineer, Process Validation.  This position is responsible for taking the lead in developing and implementing the strategy for performing process validation for commercial product candidates within AGC Biologics. The Process Validation Specialist interacts extensively across the organization and with clients & regulatory agencies in support of the drug approval process.



  • Creates and owns all aspect of Drug Substance Process Validation program; the PV program must be designed to meet expectations in accordance with FDA/EMA/ICH regulations/guidance.
  • Champions the development and implementation of new QbD platform in the Process Development operation
  • Develops and maintains strong relationships with Process Development, Manufacturing, QC and QA to support robust Process Validation platform. This will include providing support to the Manufacturing operation during batch execution.
  • Develops and maintains overall Process Validation Master Plan. Identifies support plans (e.g., bench scale characterization studies, mixing validation, etc.) required to execute at-scale Process Validation deliverables.
  • Develop and apply risk-based strategies for process validation throughout product lifecycle. This includes continuous process verification and control strategy establishment with associated enabling documents (i.e. validation or supporting technical studies).
  • Act as Subject Matter Expert (SME) in support of execution of Continued Process Verification programs and associated analyses and reports.
  • Review/author relevant technical sections of regulatory dossier or other communications to health authority.
  • Support PV initiatives globally, together with other PV professionals at our other sites.
  • Provides hands on support and technical project management in the execution and maintenance of the validation program, with support from the PD, Manufacturing, QC and QA groups.
  • Responsible for ensuring appropriate creation and review of characterization and validation protocols and reports.
  • Interacts extensively in a team environment with multi-disciplinary team from Manufacturing, QA, QC, PD, and Project Management groups.
  • Deliver presentations to clients and regulatory inspectors during inspections/audits.
  • Recognized by colleagues as a technical expert for Process Validation.
  • Act as Process validation SME for regulatory inspections and other audits.
  • As SME, Represents PV in projects/core team.



Knowledge, Skills & Abilities:

  • Must possess technical competency in process validation requirements.
  • Knowledge and understanding of current GMP regulations and industry standards regarding process validation, particularly in Biologics Drug Substance manufacturing, in compliance with FDA/EMA regulations and ICH guidelines.
  • Strong leadership skills are critical; demonstrated experience with project and personnel management skills are essential and be able to coach junior level members.
  • Candidate should have good mechanical aptitude.
  • Must be dependable, detail-oriented, organized, and be willing to perform both routine tasks and develop new skills



  • Bachelor’s Degree in Engineering or Science-related field and 10+ years of experience.
  • Master’s Degree in Engineering or Science-related field and 2+ years of experience, or
  • PhD or equivalent and 0-2+ ears of experience, may include postdoc experience. Equivalent education and experience may substitute for stated requirements.
  • Minimum of 2 years primary biotechnology cell culture and/or recovery and purification experience, preferably in clinical/commercial GMP manufacturing.
  • Minimum of 2 years of experience bringing biotechnology equipment and processes from design through GMP operational readiness.
  • Must have experience with and demonstrated understanding of Good Manufacturing Practices (GMP) and applicable regulations (e.g., ICH Q7A, 21 CFR Part 211, etc.).
  • Must have experience writing, reviewing and approving GMP documentation.




AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.


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