Process Verification Specialist mAbs

States considered:

Zoetis is the world’s largest Manufacturer and Supplier of Animal Pharmaceuticals.

At Zoetis in Lincoln, NE, we manufacture high quality medicines for dogs, cats, and livestock. Our plant has been recognized as one of the Nebraska’s Safest Companies, with a long-standing presence in the Lincoln community. We are a clean, modern site that continues to innovate and grow.

Benefits Include:

$500 Sign on Bonus

4 weeks accrued paid vacation and 13 paid holidays.

401(k) match with company profit sharing.

Tuition reimbursement and Student Loan repayment program.

Great Health, personal, and family benefits starting day 1.

Position Summary

The candidate will be responsible for supporting various activities within mAb operations not limited to closing of process in SAP, GMP review of the batch records, audit of the batch records, CAPA and change management. Understand, follow, and complete process documentation in support of GMP. Understand and follow safety policies as it relates to biological and chemical components and equipment to protect personnel and maintain product quality. This position will report directly to the manufacturing team, presence on the manufacturing floor expected.

Hours: 1st shift, Monday – Friday 7:00am – 6:00pm (40 hrs/week) occasional rotating weekends.

Position Responsibilities

• Responsible for the production batch record GMP review and 100% right first-time goal achievement.
• Assist with batch record data assembly.
• Responsible for deviation pareto board update and assist with deviation trending.
• Assist with deviation investigation and write-up (manufacturing and environmental investigations) and change management.
• Responsible for related manufacturing CAPA implementation
• Participate in daily manufacturing/Quality assurance meeting.
• Train colleagues on GMP documentation and ensure team compliance during execution and throughout review of the batch records.
• Act as a liaison and collaborate with manufacturing support groups (quality assurance and mAb technical support) to ensure respect of GMP practice and appropriate CAPA defined.
• Understand, follow, and complete process documentation in support of GMP.
• Understand and follow safety policies as it relates to biological and chemical components and equipment to protect personnel and maintain product quality.
• Participate in mAbs production process activities at least 30% of the work week.

Education and Experience

BS in Biological sciences, Biochemistry, Biotechnology or related field, MA/MS preferred. Preference given to applicants with relevant experience in mAb production.

Technical Skills and Competencies Required

Functional skills:

• Ability to read and follow written directions.
• Ability to communicate effectively both verbally and in writing.
• Ability to coach/train colleagues
• Ability to think critically.
• Ability to function independently when required.

Technical skills:

• Basic computer skills (Word and Excel)
• Proficiency in SAP
• Ability to troubleshoot.
• Proficiency in Delta V
• Knowledge in GMP environment

Desirable skills:

• Familiarity with biologic manufacturing process
• Knowledge in MODA
• Knowledge in Trackwise
• Knowledge in PWS
• Experience with lean manufacturing

Physical Position Requirements

Exposure to chemicals, fumes, odors, noise, live steam, temperature fluctuations, biohazards, continuous standing and lifting to a maximum of 50 lbs.

Full time

Regular

Colleague

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