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 Validation Engineer III/IV CSV is an enthusiastic, self-starter, self-managed individual with a strong background in Computer System Validation and/ or Automation Engineering to join the Validation Team within the Quality Group. This position will primarily contribute to the qualification of new equipment, computerized systems, and the maintenance of a validated state for existing equipment/computer systems.  Due to the intrinsic combination of systems and manufacturing equipment within the facility the computerized systems qualification is sometimes combined with the equipment qualification itself requiring a combined skillset.

 

VALIDATION RESPONSIBILITIES: 

  • Support the Validation and Quality Team in maintaining the qualified/validated state of the manufacturing and laboratory equipment.
  • Performs qualifications/ re-qualifications of Computerized and automated systems related to facilities, utilities, manufacturing and analytical equipment to demonstrate fit for use as defined within the User Requirements, Policies and Procedures.
  • Apply validation/engineering standards and company procedures to generate, execute and prepare CSV validation protocols and final reports
  • Follows URS documents, Policies, and Procedures to determine test scripts and acceptance criteria 
  • Must be able to apply GAMP 5 concepts, CFR Part 11 and Data Integrity principals and testing to validate computerized systems and maintaining the integrity of the validated state
  • Performs validation on computerized systems following current industry guidance (PDA, ISPE, IEEE)
  • Knowledge of process automation systems and process control network, software and validation strategies for automated process systems
  • Knowledge of System/Software Development Life Cycle
  • Knowledge of system validation life cycle approach and documentation
  • Assess computerized systems periodically (Periodic Reviews) to evaluate the continued validated state relative to intended use and identify any gaps related to CSV system qualification, data integrity regulatory requirements.
  • Provides technical review of validation deliverables
  • Supports/Performs Deviation Investigation through root cause determination, investigation, assessments, and/or testing, as required.
  • Supports/Performs CAPA generation for qualified systems, as required.
  • Supports and performs change control validation assessment

 

KNOWLEDGE, SKILLS & ABILITIES: 

  • Risk Analysis and Prioritization
  • Must be able to generate qualification protocols (IQ, OQ, PQ) and summary reports 
  • Must be able to apply GAMP 5, CFR Pat 11 and Data Integrity functionality testing concepts to validate computerized systems and maintain the integrity of the validated state
  • Knowledge of System/Software Development Life Cycle
  • Knowledge of system validation life cycle documentation
  • Capable of independent planning/organization/execution of personal workload.
  • 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 managers and coworkers

 

EDUCATION/EXPERIENCE:  

  • Bachelor’s degree in Life Sciences, Engineering, or related discipline with 5+ years of experience at a level III and 8 years of experience for a level IV
  • Previous experience in a regulated pharmaceutical/medical technology environment a distinct plus

 

COMPENSATION RANGE:

$94,000 - $148,610 annually

 

Fluctuations in the job market may necessitate adjustments to pay ranges. Final pay determinations will depend on various factors, including, but not limited to experience levels, knowledge, skills, and abilities.

Benefits available to Team Members include subsidized insurance for the Team Member and designated dependents (medical, vision, dental, life and disability), eligibility to participate in the AGC Biologics 401(k) plan (including a generous matching contribution from the company and immediate vesting), vacation, sick time, and parental leave.

Team Members are also eligible to receive a discretionary annual bonus commensurate to the level of the role. The payout is based on both the company’s performance and the Team Member’s performance.

 

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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