Engineering Compliance Specialist III

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

The Engineering Compliance Specialist III supports engineering and maintenance initiatives including deviation investigation and report composition, CAPA creation and closeout, Change Control Process and closure along with communication of compliance strategy to stakeholders through KPIs.

ESSENTIAL JOB DUTIES/RESPONSIBILITIES

Perform root cause analysis on Engineering deviations; create deviation reports.

Maintain facility GMP compliance; assist in ensuring regulatory inspection readiness.

Work closely with other team members to ensure project progression; represent the engineering department’s interests on multidisciplinary project teams.

Serve as liaison between multiple teams including manufacturing, quality, and process development.

Clearly communicate compliance strategy and rationale, both verbally and in written communications.

Lead investigations for manufacturing/equipment issues, bringing them to a resolution under minimal direct supervision.

Initiate appropriate corrective action/preventative action (CAPA) to prevent recurrence of deviations.

Work closely with manufacturing operations and QA team to drive CAPAs to timely closure.

Work within site quality and asset management systems.

Support quality system programs such as Deviation, CAPA, and Change Management.

Review records and assist in record closure for Lot Disposition process.

Update and revise site manufacturing SOPs.

QUALIFICATIONS

Required:

Minimum of 5+ years’ experience conducting investigation and root cause analysis in a pharmaceutical or FDA/GMP environment required.

Experience using GMP compliance in a clinical/commercial manufacturing environment required.

Strong knowledge of FDA and EU regulations for APIs and Drug Products.

Ability to understand and apply GMP regulations as they relate to manufacturing.

Strong technical writing skills.

Preferred:

B.S. in Engineering or related scientific discipline highly preferred.

Experience using quality management software (Mastercontrol, Trackwise, etc.) preferred.

Experience with asset management software (Blue Mountain, Maximo, etc.) preferred.

COMPENSATION

$83,920 - $115,390

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 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.

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