Scientific Protein Laboratories, LLC
Engineering Project Manager
Scientific Protein Laboratories, LLC, Waunakee, Wisconsin, United States, 53597
Job Summary
Join our team at Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals located just outside Madison, Wisconsin in Waunakee. SPL is an innovative biopharmaceutical leader with unique products and services supporting the pharmaceutical industry globally. For over 40 years, SPL has specialized in the development and cGMP compliant manufacturing of Active Pharmaceutical Ingredients (APIs). We have an exciting opportunity to join as an Engineering Project Manager.
Responsibilities
Provide engineering guidance and project management to complete assigned engineering projects starting with development of project scope through detail designing, budgeting, funding approval, project scheduling, construction completion and/or equipment installation, start‑up commissioning, validation, and documentation.
Develop design (process, facility, etc.) parameters for the manufacture of active pharmaceutical ingredients, including equipment and facility specifications.
Develop funding justification, seek approval, and then accomplish and control projects within funding approval.
Provide scope, hire, manage, supervise, review, and seek authorization of contracts for consulting engineering firms and construction contractors to accomplish the actual changes of processes, equipment, and facilities.
Supervise installation, start‑up, commissioning, and support validation of processing equipment.
Document performance of processing systems to achieve validation and compliance with QA and other regulatory requirements and agencies.
Design tests and methods to analyze process and utility conditions to optimize operational efficiencies and/or to meet defined process and product specifications.
Effectively manage multiple projects at the same time.
Lead cross‑functional, data‑driven troubleshooting of process and utility upsets using 5‑Why, Ishikawa, FMEA, and A3/DMAIC; convert findings into durable CAPAs.
Optimize process and clean utilities (WFI/RO, clean steam, compressed air/N₂, cleanroom HVAC pressure cascades) to improve yield, uptime, and energy/water intensity.
Design and execute DOEs to tighten control of CPPs/CQAs; translate results into setpoints, tolerances, and alarm limits with documented rationale.
Establish and maintain SPC/CPV trending and simple dashboards; act on signals (trend shifts, OOS/OOT) with timely investigations.
Institutionalize gains through cGMP change control: update URS/specs, redlines/as‑builts, SOPs, and training; ensure re‑qualification (IQ/OQ/PQ) where required.
Strengthen asset reliability via criticality analysis and CMMS‑backed PM/PdM (e.g., vibration, thermography), and close out punch lists with pristine documentation.
Qualifications
Bachelor’s degree in engineering required (mechanical or chemical preferred).
5+ years of experience required; 10+ years preferred.
Working toward WI Professional Engineer License with FE Test.
Benefits
Competitive compensation
Excellent benefits package – Medical, Dental, and Vision on Day 1
Life and AD&D Insurance, Short and Long‑term Disability
Health and Flexible Spending Account options
Employee Assistance Program
Generous vacation, paid holidays
401k
Advancement opportunities, team‑oriented environment, community involvement, company events
SPL is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law.
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Responsibilities
Provide engineering guidance and project management to complete assigned engineering projects starting with development of project scope through detail designing, budgeting, funding approval, project scheduling, construction completion and/or equipment installation, start‑up commissioning, validation, and documentation.
Develop design (process, facility, etc.) parameters for the manufacture of active pharmaceutical ingredients, including equipment and facility specifications.
Develop funding justification, seek approval, and then accomplish and control projects within funding approval.
Provide scope, hire, manage, supervise, review, and seek authorization of contracts for consulting engineering firms and construction contractors to accomplish the actual changes of processes, equipment, and facilities.
Supervise installation, start‑up, commissioning, and support validation of processing equipment.
Document performance of processing systems to achieve validation and compliance with QA and other regulatory requirements and agencies.
Design tests and methods to analyze process and utility conditions to optimize operational efficiencies and/or to meet defined process and product specifications.
Effectively manage multiple projects at the same time.
Lead cross‑functional, data‑driven troubleshooting of process and utility upsets using 5‑Why, Ishikawa, FMEA, and A3/DMAIC; convert findings into durable CAPAs.
Optimize process and clean utilities (WFI/RO, clean steam, compressed air/N₂, cleanroom HVAC pressure cascades) to improve yield, uptime, and energy/water intensity.
Design and execute DOEs to tighten control of CPPs/CQAs; translate results into setpoints, tolerances, and alarm limits with documented rationale.
Establish and maintain SPC/CPV trending and simple dashboards; act on signals (trend shifts, OOS/OOT) with timely investigations.
Institutionalize gains through cGMP change control: update URS/specs, redlines/as‑builts, SOPs, and training; ensure re‑qualification (IQ/OQ/PQ) where required.
Strengthen asset reliability via criticality analysis and CMMS‑backed PM/PdM (e.g., vibration, thermography), and close out punch lists with pristine documentation.
Qualifications
Bachelor’s degree in engineering required (mechanical or chemical preferred).
5+ years of experience required; 10+ years preferred.
Working toward WI Professional Engineer License with FE Test.
Benefits
Competitive compensation
Excellent benefits package – Medical, Dental, and Vision on Day 1
Life and AD&D Insurance, Short and Long‑term Disability
Health and Flexible Spending Account options
Employee Assistance Program
Generous vacation, paid holidays
401k
Advancement opportunities, team‑oriented environment, community involvement, company events
SPL is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law.
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