Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

JOB SUMMARY:

AGC Biologics is seeking an energetic and enthusiastic individual with a background in Biologics, Pharmaceutical Validation, and/or Engineering to join the Validation Team as a Validation Engineer II within the Quality Group. This position will focus on the qualification of production equipment and bench-scale instruments used in upstream cell culture, downstream purification, controlled temperature units, SIP cycle qualification, new equipment qualification, and maintaining the validated state.

PRINCIPAL RESPONSIBILITIES:

• Maintain assigned tasks in the Workforce Plan​
• Performing BMRAM Approvals for asset inactivation, activation, decommissioning​
• Support Observations, Deviations, and CAPAs by providing SME information/data, review, and may be responsible for supplemental protocol and/or Actions​
• Able to and may be asked to perform backroom support for regulatory audits, client audits, internal audits, inspections, and site visits​
• Author, analyze, review and approval for risk assessment with the guidance of the process owner​
• Updating Validation process-related SOPs/ Templates and with the guidance of the process owner​

KNOWLEDGE, SKILLS & ABILITIES:

• Ability to generate qualification protocols (IQ, OQ, PQ) and summary reports.
• Proficiency in performing temperature mapping using Kaye Validator and ValProbes systems.
• Knowledge of the system validation life-cycle concept.
• Capable of planning, organizing, and executing personal workload independently.
• Strong ability to manage multiple simultaneous projects and deadlines.
• Excellent written and oral communication skills to develop technical documentation and interact with team members.
• Effective at presenting information to managers and coworkers.

EDUCATION/EXPERIENCE:

• Bachelor’s degree in Life Sciences, Engineering, or a related discipline with 2-4+ years of experience in biotech or pharmaceutical systems qualification. Additional manufacturing experience is a plus.
• Previous experience in a regulated biologics manufacturing environment is a distinct advantage.
• Support the creation/update of Product Asset Summary Report​
• Able to provide guidance on the Validation process, seeking guidance from the Process Owner where required​
• Revalidation/Periodic Review execution ​
• Perform tactical work for the execution of QMS Validation sub-processes​
• Change Control Assessments​
• Review/approvals of Validation Plan​
• Review/approvals of Requirements Specification​
• Review/approvals of Design Specification​
• Review/approvals of Data Integrity Risk Assessment ​
• Creation/reviews/approvals/execution of protocols (IQ/OQ/PQ)​
• Cross functional scheduling of protocol execution​
• Create/review/approvals of Requirements Traceability Matrix​
• Review/approvals of Asset Administration Standard Operating Procedures​
• Create/review/approvals of Validation Summary Report
• Equivalent education and experience may substitute for stated requirements.

Compensation Range

$74,960 - $103,030, with annual bonus eligibility

Schedule

M-F

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com. Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook!

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.