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 primarily contribute to the qualification of new equipment, controlled temperature unit mapping and the maintenance of a validated state for existing equipment.
- Performs qualification/requalification of facilities, utilities, manufacturing to demonstrate that the equipment is fit for its intended use.
- Apply validation/engineering concepts and company procedures to generate validation protocols and reports.
- Determine test scripts and acceptance criteria according to system URS requirements.
- Investigate, resolve and close deviations and associated CAPAs.
- Performs temperature mapping studies for controlled temperature units, autoclaves, SIP systems as part of qualification activities.
- Provides technical review of validation data and deliverables.
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.
- 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 2+ years of experience.
- Previous experience in a regulated pharmaceutical, biotechnology or 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.