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 www.agcbio.com.

 

SUMMARY:

The Manager/Senior Manager, Validation will be responsible for coordinating the activities of the Validation group for qualification of facilities, utilities and equipment (FUE) for GMP use. The manager will also be responsible for the execution of cleaning validation and shipping qualification, as required, in support of product commercialization. During regulatory inspections and client audits, the validation manager is the primary contact/SME for all FUE related requests.

 

PRINCIPAL RESPONSIBILITIES:

  • Management of Validation departmental resources to qualify/requalify facilities, utilities, manufacturing and analytical equipment, including automated and computerized equipment to meet equipment lifecycle requirements
  • Tracking and reporting of metrics related to qualification activities
  • Application of validation/engineering concepts and company procedures to generate validation protocols and reports
  • Evaluation of current regulatory and industry guidelines to maintain compliant qualified status for all systems
  • Investigation, resolution and closure of deviations and associated CAPAs
  • Technical review of validation deliverables
  • Subject Matter Expert (SME) for qualification during audits and inspections

 

KNOWLEDGE, SKILLS & ABILITIES:

  • Extensive knowledge of relevant regulatory guidelines, including, but not limited to:
    • CFR21 Parts 11, 210, 211 and 820
    • ICH Q7
    • FDA/EMEA Data Integrity Guidelines
    • Application of EN285 to steam sterilization processes
  • Creation of Validation Master Plans
  • Planning/organization/execution of workload for the entire validation team
  • Ability to manage multiple simultaneous projects and deadlines
  • Must have excellent written communication skills to develop and write technical presentations and documentation
  • Must be capable of effectively presenting information to senior management, peers, clients and regulatory authorities
  • Previous direct experience with regulatory inspections a distinct plus

 

EDUCATION/EXPERIENCE:

  • Bachelor’s degree in Life Sciences, Engineering, or related discipline or equivalent experience
  • 10+ years of relevant experience in a regulated pharmaceutical/medical technology or FDA/GMP environment
  • Demonstrated ability to effectively manage staff and multiple tasks utilizing organization and prioritization skills, driven to meet timelines and results-oriented

 

COMPENSATION RANGE:

$112,583 - $155,400

 

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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