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 and cell and gene therapies. 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.
The Validation Engineer II/ III CSV is an enthusiastic individual with a strong background in Computer Systems Validation to join the Validation Team within the Quality Group. This position will primarily contribute to the qualification of computerized cGMP systems, new equipment, and the maintenance of a validated state for existing systems and equipment.
- Performs qualifications/ re-qualifications of facilities, utilities, manufacturing and analytical equipment to demonstrate that the equipment is fit for its intended use.
- Apply validation/engineering concepts and company procedures to generate validation protocols and reports.
- Follows provided URS documents to determine test scripts and acceptance criteria.
- Investigate, resolve and close deviations and associated CAPAs.
- Performs validation of computerized systems following GAMP 5 guidance.
- Performs gap assessments on computerized systems to identify gaps related to data integrity.
- Performs periodic reviews of computerized systems.
- Provides technical review of validation deliverables.
KNOWLEDGE, SKILLS & ABILITIES:
- Must be able to generate qualification protocols (IQ, OQ, PQ) and summary reports.
- Must be able to apply GAMP 5 concepts to validate computerized systems that are released while maintaining the integrity of the validated state.
- Knowledge of system validation “life-cycle” concept.
- 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 communicating and presenting information to managers and coworkers.
- Bachelor’s degree in Life Sciences, Engineering, Computer Science or related discipline with 2+ years of experience in a cGMP manufacturing or development environment.
- Previous experience in a regulated pharmaceutical, biotechnology, medical device environment a distinct plus.
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.