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. 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 a senior validation lead within the team responsible for qualification and validation of facilities, utilities and production equipment maintaining the qualified state throughout the system lifecycle.
- Performs qualifications/ re-qualifications of facilities, utilities, and manufacturing equipment to demonstrate that the equipment is fit for its intended use
- Responsible for generation of validation master plans, protocols and reports
- Participates in tech transfer for new products determining impact and required system qualification
- Participate in customer tech transfer meetings interfacing with functional groups and the customer
- Apply validation/engineering concepts and company procedures to generate validation protocols and reports
- Follows URS documents to determine test scripts and acceptance criteria
- Investigate, resolve and close deviations and associated CAPAs
- Provides technical review of validation deliverables
- Evaluate, write and perform validation program procedures
KNOWLEDGE, SKILLS & ABILITIES:
- Must be able to generate qualification protocols (IQ, OQ, PQ) and summary reports
- Must be able to perform temperature mapping and steam sterilization cycle validation activities and using the Kaye Validator and ValProbes systems
- Must be capable of defining an equipment grouping strategy and identifying the worst-case systems and equipment.
- Support cleaning validation execution activities.
- Knowledge of system validation “life-cycle” concept.
- Capable of independent planning/organization/execution of personal workload.
- Ability to manage multiple simultaneous projects and deadlines, supervise and manage contracted and internal resources to accomplish validation project requirements.
- 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
- Must be able to write and perform validation program procedures using technical writing pricipals.
- Bachelor’s degree in Life Sciences, Engineering, or related discipline with 10+ years of experience
- Previous experience in a regulated pharmaceutical, biotechnology or medical technology environment a distinct plus
Compensation range for this positions is $87,417-$135,100 dependent upon level placed, experience and education
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.