Process Development Engineer

Scientific Protein Laboratories; Waunakee (WI); On-site; USD 85,000 - 125,000; Full time

Benefits offered by this job

Competitive compensation

Medical, Dental and Vision on Day 1

Life and AD&D Insurance

Short and Long-term Disability

Health Savings Account options

Flexible Saving Account options

Employee Assistance Program

Generous vacation

Paid Holidays

401k

Advancement opportunities

Team-oriented environment

Community involvement

Company events

Job summary

Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals, invites qualified candidates for a Process Development Engineer position in Waunakee, WI. You will lead scale-up and technology transfer from lab and pilot development to commercial manufacturing, ensuring product quality and process robustness.

The role requires a BS in chemical engineering or related field, 3 years of relevant experience (5+ preferred), and hands-on expertise with process design, scale-up, and

Qualifications

• Bachelor’s degree in chemical engineering or related engineering discipline.
• 3 years of relevant industrial experience; 5+ years in process development preferred.
• Hands-on experience with process design, development, scale-up, technology transfer, and manufacturing equipment.
• Strong knowledge of process engineering principles used in pharmaceutical or biotechnology manufacturing.
• Experience in pharmaceutical manufacturing, biologics, or related R&D preferred.
• Excellent analytical, problem-solving, technical writing, and communication skills.
• Ability to work effectively in cross-functional teams and manage multiple priorities in a fast-paced manufacturing environment.

Responsibilities

• Lead the scale-up and technology transfer of new product manufacturing processes from laboratory and pilot-scale development to commercial manufacturing.
• Implement, and optimize commercial manufacturing processes to ensure product quality, process robustness, and operational efficiency.
• Identify process equipment and operating parameters for new manufacturing processes. Collaborate with Engineering and external equipment vendors to evaluate and implement manufacturing technologies.
• Prepare process flow diagrams (PFDs), mass balances, process analyses, expected yield calculations, and manufacturing instructions.
• Design, coordinate, and execute engineering batches to support process development, process optimization, and technology transfer activities.
• Prepare technical reports, development protocols, SOPs, equipment operating instructions, and other engineering and manufacturing documentation.
• Analyze manufacturing and production data to identify trends, improve process performance, maximize yields, and proactively prevent manufacturing issues.
• Provide technical support for manufacturing operations, including troubleshooting, deviation investigations, root cause analysis, and implementation of corrective and preventive actions (CAPAs).
• Support the qualification and validation of manufacturing equipment and processes, including IQ, OQ, and PQ activities.
• Train Operations personnel on new manufacturing processes, process improvements, and equipment.
• Participate as a technical representative on cross-functional project teams supporting internal initiatives and customer programs.
• Serve as a technical interface with CDMO clients by supporting process development, technology transfer, and project execution activities.
• Ensure all activities are conducted in compliance with cGMP requirements, company procedures, and applicable regulatory standards.

Skills

Process development

Scale-up

Technology transfer

Process design

Analytical skills

Cross-functional teamwork

Education

Bachelors in chemical engineering

Tools

Process equipment

Job description

Job DetailsJob Location: Scientific Protein Laboratories - Waunakee, WI 53597Position Type: Full TimeEducation Level: 4 Year DegreeJob Shift: DayJob Category: EngineeringJOB 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 Process Development Engineer.

Responsibilities

• Lead the scale-up and technology transfer of new product manufacturing processes from laboratory and pilot-scale development to commercial manufacturing.
• Implement, and optimize commercial manufacturing processes to ensure product quality, process robustness, and operational efficiency.
• Identify process equipment and operating parameters for new manufacturing processes. Collaborate with Engineering and external equipment vendors to evaluate and implement manufacturing technologies.
• Prepare process flow diagrams (PFDs), mass balances, process analyses, expected yield calculations, and manufacturing instructions.
• Design, coordinate, and execute engineering batches to support process development, process optimization, and technology transfer activities.
• Prepare technical reports, development protocols, SOPs, equipment operating instructions, and other engineering and manufacturing documentation.
• Analyze manufacturing and production data to identify trends, improve process performance, maximize yields, and proactively prevent manufacturing issues.
• Provide technical support for manufacturing operations, including troubleshooting, deviation investigations, root cause analysis, and implementation of corrective and preventive actions (CAPAs).
• Support the qualification and validation of manufacturing equipment and processes, including IQ, OQ, and PQ activities.
• Train Operations personnel on new manufacturing processes, process improvements, and equipment.
• Participate as a technical representative on cross-functional project teams supporting internal initiatives and customer programs.
• Serve as a technical interface with CDMO clients by supporting process development, technology transfer, and project execution activities.
• Ensure all activities are conducted in compliance with cGMP requirements, company procedures, and applicable regulatory standards.

Job Requirements and Qualifications

• Bachelor’s degree in chemical engineering or related engineering disciple.
• Minimum of 3 years of relevant industrial experience, 5+ years of process development experience in pharmaceutical, biotechnology or CDMO environments is preferred.
• Hands-on experience with process design, process development, scale-up, technology transfer, and manufacturing equipment.
• Strong knowledge of process engineering principles and engineering methods used in pharmaceutical or biotechnology manufacturing.
• Experience in pharmaceutical manufacturing, biologics, or related research and development environments is preferred.
• Excellent analytical, problem-solving, technical writing, and communication skills.
• Ability to work effectively in cross-functional teams and manage multiple priorities in a fast-paced manufacturing environment.

Why join SPL?

• 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