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Validation & Engineering Group

ZL01-101525 Sr Engineer

Validation & Engineering Group, De Pere, Wisconsin, United States

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Job Description Validation & Engineering Group, Inc.

(V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

Senior Engineer

Education:

Doctorate OR Masters + 2 years of Engineering experience OR Bachelors in Engineering + 4 years of Engineering experience.

Attributes:

• Experience in biotechnology or pharmaceutical field, downstream process, managing SOPs, eBRs and change controls. Initiate, revise, and approve manufacturing‑controlled documents in the document management system. Serve as document author, owner, reviewer, or data verifier as needed, ensuring all controlled documents accurately reflect current operations and compliance standards. • Implement new product introductions and major projects within Drug Substance (DS) operations. Collaborate with Capital and cross‑functional teams to define requirements, develop operational strategies, and implement deliverables, including procedures, batch records, automation, materials, new equipment introduction/modifications, cleaning, changeover, process validation, training and floor readiness. • Analyze floor operations data and observations to identify root causes of deviations or inefficiencies. Develop and implement data‑driven solutions to drive process improvements and enhance operational performance. • Ensure timely investigation and resolution of deviations within established goals. Perform deviation assessments, support root cause analysis (RCA), human performance evaluations …

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