Process Engineer – Biological Manufacturing Upstream & Downstream

Zoetis•Lincoln, NE

33d•Onsite

About The Position

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: 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. Review automation recipes. May be responsible for supervision of up to 4 colleagues.

Requirements

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
Experience with working in a GMP environment preferred.
Experience with mAb or biological production (upstream) and purification (downstream) at large scale or small scale.
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.
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.

Nice To Haves

Knowledge of quality system such as TrackWise is a plus.
Ability to engage and collaborate with others, and to lead projects.
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.

Responsibilities

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.
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.
Review automation recipes.
May be responsible for supervision of up to 4 colleagues.