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 primarily contribute to the qualification of new equipment, and the maintenance of a validated state for existing equipment.
Qualification/requalification of facilities, utilities, manufacturing and analytical equipment including automated equipment
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Application of validation/engineering concepts and company procedures to generate validation protocols and reports
Evaluation of specifications to determine test scripts and acceptance criteria
Deviation resolution including mechanical troubleshooting and root cause analysis
Technical review of validation deliverables
KNOWLEDGE, SKILLS & ABILITIES:
IQ, OQ creation and execution
KAYE validator use
Good mechanical aptitude
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 3+ years of experience
Previous experience in a regulated pharmaceutical/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. EOE
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