Job DetailsJob Location: Scientific Protein Laboratories - Waunakee, WI 53597Position Type: Full TimeJOB SUMMARY Join our team at Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals, locat…
Job DetailsJob Location: Scientific Protein Laboratories - Waunakee, WI 53597Position Type: Full TimeJOB SUMMARY Join our team at Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals, locat…
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Full-time
high school, bachelor degree
Medical Insurance, Dental Insurance, Vision Insurance, Life Insurance, AD&D Insurance, Short-term Disability
Posted 53d ago
~40 hrs/week
Responsibilities
The role ensures manufacturing operations comply with regulatory requirements and quality standards by leading investigations into deviations and implementing CAPAs. It also involves authoring controlled documentation and driving continuous improvement initiatives to enhance operational efficiency.
Requirements
A high school diploma is required, while a bachelor's degree in Chemistry, Biological Sciences, or a related field is preferred. Candidates must have at least 2 years of experience in a cGMP manufacturing environment and 1 year of experience leading deviation investigations.
Full job description
Job DetailsJob Location: Scientific Protein Laboratories - Waunakee, WI 53597Position Type: Full TimeJOB SUMMARY
Join our team at Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals, located just outside of 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 specializes in the development and cGMP compliant manufacturing of Active Pharmaceutical Ingredients (APIs). SPL has an exciting opportunity to join the team as a Manufacturing Process and Compliance Engineer.
The Manufacturing Process and Compliance Engineer is responsible for ensuring manufacturing operations are conducted in compliance with applicable regulatory requirements, quality standards, and internal procedures. This role leads investigations of manufacturing deviations, authors and implements Corrective and Preventive Actions (CAPAs), maintains manufacturing documentation, and drives continuous improvement initiatives to enhance product quality, process efficiency, and operational excellence.
Responsibilities include
Lead and document investigations related to manufacturing deviations, non-conformances, out-of-specification (OOS) events, and quality issues to determine root cause and assess product impact. Develop, implement, and track CAPAs to ensure timely and effective resolution of quality and compliance issues. Author, revise, review, and approve manufacturing Standard Operating Procedures (SOPs), work instructions, batch records, and other controlled documents to maintain compliance and operational effectiveness. Collaborate with cross-functional teams including Manufacturing, Quality Assurance, Quality Control, Engineering, Validation, and Supply Chain to resolve production and compliance-related issues. Support internal and external audits, regulatory inspections, and compliance assessments by providing technical expertise and documentation. Perform root cause analysis using structured problem-solving methodologies such as 5 Whys, Fishbone Diagrams, and Failure Mode and Effects Analysis (FMEA). Monitor manufacturing processes and quality metrics to identify trends, risks, and opportunities for improvement. Lead and support continuous improvement projects focused on process optimization, waste reduction, cycle-time improvement, and operational efficiency. Evaluate proposed process changes through change control systems and assess potential impacts on product quality, regulatory compliance, and manufacturing performance. Ensure compliance with current Good Manufacturing Practices (cGMP), company policies, and applicable regulatory requirements. Participate in risk assessments, process validations, and implementation of corrective actions resulting from audit findings or quality events.
Job Requirements and Qualifications
Education: High School diploma or G.E.D. required, Bachelor's Degree or above in Chemistry, Biological Sciences, or related discipline preferred
Experience: 2 plus years experience cGMP Manufacturing environment required, 1 plus year experience leading or reviewing deviation investigations
WHY JOIN SPL?
Our employees are our success! We recruit motivated people, recognize their contributions, and support their development to reach their full potential.
Perks include: competitive compensation; excellent benefits package - including Medical, Dental and Vision on Day 1; Life and AD&D Insurance, and Short and Long-term Disability; Health and Flexible Saving Account options; Employee Assistance Program, generous vacation; paid Holidays; 401k; advancement opportunities; team-oriented environment; community involvement; company events and more!
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. Qualifications
Scientific Protein Laboratories (SPL) has been a leading global supplier of high quality active pharmaceutical ingredients (APIs) for over three decades. We specialize in cGMP biopharmaceutical manufacturing and are among the largest commercial suppliers of Heparin Sodium USP, Pancreatin USP, and Pancrelipase USP. We serve the pharmaceutical, veterinary, and food industries globally. Our manufacturing facility is located in Waunakee, Wisconsin.
Offices: 700 E Main St, Waunakee, Wisconsin 53597, US
Health CareBiotechnologyManufacturingPharmaceutical
Based on 1180 listings with disclosed salaries, most engineering jobs in Wisconsin pay between $69k–$156k per year. Individual offers vary with seniority, company size, and specialization.
How many Engineering jobs are open in Wisconsin right now?
There are currently 6,007 open engineering positions in Wisconsin listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Engineering roles in Wisconsin?
Companies currently hiring include Eaton, Milwaukee Tool, FTI, Generac, Catalent, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Engineering jobs in Wisconsin?
Yes — 773 of the 6007 open engineering positions offer remote or hybrid work (170 remote, 603 hybrid).
How do I apply for Engineering jobs in Wisconsin?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.