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 Biologics or Pharmaceutical manufacturing systems validation and/or Engineering to join the Validation Team within the Quality Group. This position will primarily contribute to qualification of upstream cell culture and downstream purification systems and equipment, new equipment, and maintaining the validated state. This individual will take ownership of production systems validation and be responsible for execution of the validation master plan.
- Authors, reviews and executes validation protocols in conjunction with engineering, manufacturing and QA personnel.
- Performs qualification of manufacturing and analytical equipment including media hold studies, media fills, facilities, clean utilities to demonstrate that equipment and equipment preparations are fit for use in the manufacturing process.
- Develop risk based strategies for production equipment qualification, system grouping, process control and product quality impacting functionality focused testing.
- Apply validation/engineering concepts and company procedures to generate validation protocols and reports.
- Develop validation system procedures and methods to ensure compliance and efficiency.
- Determine test scripts and acceptance criteria according to URS requirements.
- Investigate, resolve and close deviations and associated CAPAs.
- Provides technical review of validation data, deliverables and develop final summary reports.
- Take ownership of production systems from a validation perspective and perform impact assessment for change control, assist in investigations and CAPA.
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 and oral communication skills to develop technical documentation and communicate with internal and external department team members.
- 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 biologicals manufacturing 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.