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 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 be responsible for qualification and validation of facilities, utilities and production equipment maintaining the qualified state throughout the system lifecycle.
- Performs qualification/requalification of facilities, utilities, and manufacturing 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.
- Develops test scripts and acceptance criteria relative to system URS requirements.
- Investigate, resolve and close deviations and associated CAPAs.
- Provides technical review of validation deliverables.
- Perform temperature mapping, autoclave and SIP cycle qualifications.
KNOWLEDGE, SKILLS & ABILITIES:
- Must be able to generate qualification protocols (IQ, OQ, PQ) and summary reports.
- Must be able to perform temperature mapping activities and using the Kaye Validator and ValProbes systems.
- Knowledge of system validation “life-cycle” concept.
- Must have excellent written communication skills to develop and write procedures, protocols, reports and technical presentations.
- Must be capable of effectively presenting information to managers and coworkers.
- Must be able to write and perform validation program procedures using technical writing principles.
- Bachelor’s degree in Life Sciences, Engineering, or related discipline with 2+ years of experience.
- Previous experience in a regulated pharmaceutical, biotechnology or medical technology 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.