Process Development Engineer: Scale-Up & Tech Transfer

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

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