Process Engineer - Biological Manufacturing Upstream & Downstream

Process Engineer - Biological Manufacturing Upstream & Downstream

Join to apply for the Process Engineer - Biological Manufacturing Upstream & Downstream role at Zoetis

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 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:

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

Monitor monoclonal antibody (mAb) batch performance and investigate outliers. Assist with deviation resolution and effective CAPA implementation. Lead and drive technical improvements in our monoclonal antibody (mAb) manufacturing processing area and troubleshoot complex technical challenges.

Hours: 1st Shift with on-call rotation. Weekends and holiday may be needed to support business needs.

Position Responsibilities

Looking for a strong technical leader in biologic manufacturing to drive technical improvements in our monoclonal antibody (mAb) manufacturing processing area and troubleshoot complex technical challenges.

• Lead technical discussions between area team leaders and their respective team, small scale process experts, and quality assurance delegates to assist with deviation closing.
• Participate in CAPA implementation and manage effectiveness check.
• Monitor and report of key process indicators (KPI).
• Investigate outliers and implement lasting changes to drive process efficiency and robustness.
• Participate in the introduction of new production processes and site to site transfers in collaboration with Global Manufacturing Technology.
• Maintain state of the art competence on technological developments within area of responsibility and recommend equipment and/or process enhancements that will provide improved efficiencies, safety, and a competitive advantage.
• Draft and manage SOPs, batch records, and risk assessments.
• Work cross-functionally with multiple teams to ensure mAbs delivers the highest quality products and provide the team with the tools, resources and technical support needed to achieve their goals.
• Assist with technical projects within the mAb area.
• May be responsible for supervision of up to 4 colleagues.

Education and Experience

• Degree in Biological Sciences, Chemical Engineering, Biochemistry, or in any relevant disciplines is required.
• Expectation of minimal relevant experience requirement:
  Bachelor + 6 - 8 years, Master + 3 - 5 years, PhD + 1- 2 years

Technical Skills and Competencies Required

The ideal candidate would possess:

• Experience with working in a GMP environment preferred.
• Experience with mAb or biological production (upstream) and purification (downstream) at large scale or small scale.
• Knowledge of quality system such as Track Wise is a plus.
• Ability to engage and collaborate with others, and to lead projects.
• Analytical driven with understanding of data trending and statistics.
• Strong understanding of aseptic technique, cell culture, centrifugation, depth filtration, chromatography, tangential flow filtration and nanofiltration.
• Knowledge in chromatography software such as AKTA Unicorn platform and other automation (e.g., Delta V) is a plus.
• Demonstrated understanding of Lean Manufacturing concepts and principles preferred.
• Excellent communication (written and oral) with attention to detail.
• Self-starter, able to prioritize work on multiple concurrent projects and work efficiently with minimal guidance.
• Strong computer, scientific, and organization skills.
• Demonstrated record of working in a team environment.

Physical Position Requirements

• Exposure to chemicals, fumes, odors, noise, live steam, temperature fluctuations and biohazards:
  All of which Zoetis makes as safe as possible for the colleagues.
• Must wear appropriate gowning and PPE (Personal Protective Equipment) in manufacturing/production areas.
• The colleague may be required to work greater than 40 hours per week, including weekends and holidays to support the business.

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