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.
AGC Biologics is seeking a Senior Validation Engineer with CIP & SIP cleaning experience. The ideal candidate will be an energetic and enthusiastic individual with a strong background in Validation or Engineering to join the Validation Team within the Quality Group. This position will primarily contribute to the cleaning validation and cleaning monitoring program.
- Performs cleaning validation activities associated with the generation of validation master plans, protocols and reports.
- Develops cleaning validation strategies following a matrix approach based on risk.
- Evaluates the introduction of new products to determine if cleaning validation activities are required.
- Participates in the development of cleaning cycles and procedures.
- Apply validation/engineering concepts and company procedures to generate validation protocols and reports.
- Manages the cleaning validation and cleaning monitoring programs.
- Follows URS documents to determine test scripts and acceptance criteria.
- Investigate, resolve and close deviations and associated CAPAs.
- Provides technical review of validation deliverables.
KNOWLEDGE, SKILLS & ABILITIES:
- Must be able to generate qualification protocols (IQ, OQ, PQ) and summary reports.
- Experience required in CIP/SIP within a Biologics manufacturing corporation.
- Must be capable of taking cleaning validation samples, defining an equipment grouping strategy and identifying the worst-case correlation between products, cleaning procedures and equipment.
- 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 presenting information to managers and coworkers.
- Bachelor’s degree in Life Sciences, Engineering, or related discipline with 5+ years of experience.
- Previous experience in a regulated pharmaceutical/biologics environment is a 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.