JOB OBJECTIVE: Design and implement processes and process equipment for technology transfer, scale-up, and production for chemical and biological processes to make Promega’s products. Assist Manufacturing Operations in problem solving with regards to production and analytical equipment and systems. Ensure that processes and designs are compatible for new product technology transfer and establish future process and equipment automation technology which will deliver expected product quality.
1. Work with Engineering personnel, Facilities Services, Production Scientists, R&D, and outside experts, and labs to develop new and improved production processes. Develop the business case to support new production processes and equipment.
2. Participate in creation of detailed equipment specifications in support of procurement and implementation of new process and process utility systems.
3. Implement Medical Device (IVD) industry process development and control practices within manufacturing. Use appropriate applied statistical methods in design of tests and analysis of results.
4. Support automation of processes with product manufacturing process descriptions, flow diagrams, and requirements for material and personnel flow within new and existing production lines.
5. Work with QA to develop and characterize critical process parameters that establish process and equipment specifications as well as acceptance criteria for qualification testing.
6. Participate in Corrective Action/Preventative Action (CAPA) Investigations that have the potential to improve product manufacturing systems.
7. Project Management – Participate in cross-functional teams to develop process objectives, evaluate alternative approaches, and develop plans and timelines. Communicate and present project status reports to management and company personnel. Monitor project progress and work with team members and management to address issues.
8. Communication – Prepare and deliver project status presentations to customer groups and Promega Management, including required Capital Governance Process stage gate presentation.
9. Understands and complies with ethical, legal and regulatory requirements applicable to our business.
1. Participate in process and/or equipment Validation protocol development and test execution activities.
2. Present updates and departmental information at various company meetings.
1. Bachelor’s degree in Chemical, BioProcess, Process, or equivalent Engineering.
2. Experience with engineering process systems for manufacturing.
3. Excellent organization, communication, and presentation skills.
4. Ability to handle both multiple and changing priorities.
1. Demonstrated successful experience designing and implementing GMP process systems (e.g., fermentation, purification, chromatography, compounding, CIP/SIP, USP water or WFI).
2. Experience in Lyopholization and/or spray drying.
3. Automation Engineering experience (e.g., ANSI/ ISA S-88 Batch control levels)
4. Solid computer skills and working knowledge of Word, Excel, and PowerPoint.
5. Experience with engineering process systems for manufacturing within FDA GMP regulatory environment.
6. Master’s degree in engineering or scientific discipline.
1. Ability to work in a production environment around automated equipment.
2. Ability to work in an office environment utilizing a computer workstation.
3. Ability to work in a lab environment with chemical, biological and packaging materials.
4. Ability to travel by car or airplane, for one or several days, to suppliers, equipment vendors, trade shows, etc.
Diversity is important at Promega. We are proud to be an Equal Opportunity Employer, and make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.