Engineering Project Manager
On-site · Waunakee, Wisconsin, United States
Job Summary
Engineering Project Manager at Scientific Protein Laboratories (SPL) outside Madison, WI, overseeing planning, budgeting, and cross-functional management of API-process and facility-expansion projects. Responsibilities include defining project scope, design parameters for API manufacturing, funding approvals, contract management for engineering firms and contractors, supervision of installation and commissioning, and ensuring validation/compliance with QA and regulatory requirements. The role emphasizes DOEs to tighten CPPs/CQAs, DOE-based process optimization, CAPA-driven improvements, SPV/QP-driven validation activities, and maintenance of SPC/CPV dashboards for trend analysis and investigations.
Required Qualifications
- Bachelor’s degree in engineering (mechanical or chemical preferred)
- 5+ years of engineering/project management experience
- Knowledge of cGMP and regulatory requirements for pharmaceutical manufacturing
- Experience leading cross-functional teams and managing multiple projects
- Experience with design, construction, commissioning, qualification (IQ/OQ/PQ) and validation
Desired Qualifications
- Bachelor’s degree in engineering
- 5+ years of experience in engineering or project management (required)
- 10+ years of experience preferred
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