Process Development 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 Process Development Engineer. The Process Development Engineer provides technical and engineering expertise to support SPL's process development and manufacturing activities. This role is responsible for the development, scale-up, optimization, and technology transfer of manufacturing processes from the laboratory and pilot scale development through commercial GMP manufacturing. The Process Development Engineer performs Engineering analyses to develop robust manufacturing processes and process specifications that meet product quality, performance, and regulatory requirements. This position provides technical expertise on manufacturing technologies, process design, equipment selection, materials, and process capabilities and applies sound engineering principles to solve technical challenges and recommend effective process solutions.
Responsibilities include:
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 discipline.
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?
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.
