Manufacturing Process and Compliance Engineer

Manufacturing Process and Compliance Engineer

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.