6577 - Senior Process Engineer
Verista•Madison, WI
About The Position
Verista is seeking an experienced Process Engineer – Manufacturing Science and Technology (MSAT) to support GMP biologics drug substance manufacturing. This role will focus on technology transfer, process scale-up, manufacturing support, and technical troubleshooting within a CDMO environment. The ideal candidate will have strong upstream and/or downstream biologics experience, GMP knowledge, and excellent client-facing communication skills.
Requirements
- Bachelor's degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related discipline.
- Experience in MSAT, process engineering, or process development within biologics manufacturing.
- Strong technology transfer experience supporting GMP biologics drug substance manufacturing.
- Hands-on knowledge of upstream and/or downstream manufacturing processes.
- Experience with process scale-up, process design, and manufacturing optimization.
- Experience developing or reviewing Master Batch Records and GMP documentation.
- Knowledge of QTPPs, CQAs, CPPs, and biologics process development.
- Experience with GMP quality systems, including deviations, CAPAs, change controls, and impact assessments.
- Excellent communication, interpersonal, and client-facing skills.
- Ability to work independently and provide technical expertise with minimal training.
Nice To Haves
- Previous MSAT experience within a CDMO environment.
- Experience with both upstream and downstream biologics operations.
- Experience with bioreactors, cell culture, chromatography, filtration, or UF/DF.
- Experience supporting process characterization, PPQ, and process validation.
- Direct experience managing client-facing technology transfer activities.
Responsibilities
- Serve as a technical Subject Matter Expert (SME) supporting GMP biologics drug substance manufacturing.
- Lead technology transfer activities from process development and external clients into manufacturing.
- Support process development, scale-up, optimization, and manufacturing process design.
- Develop, review, and maintain Master Batch Records (MBRs) and manufacturing documentation.
- Provide technical expertise for upstream and/or downstream biologics manufacturing operations.
- Support deviation investigations, impact assessments, CAPAs, change controls, and other QMS activities.
- Evaluate process parameters, CQAs, CPPs, and Quality Target Product Profiles (QTPPs).
- Troubleshoot manufacturing issues and implement process improvements.
- Collaborate with Manufacturing, Quality, Engineering, and external clients to ensure successful process execution.
- Support process characterization, validation, and manufacturing readiness activities.
Benefits
- High growth potential and fast-paced organization with a people-focused culture
- Competitive pay plus performance-based incentive programs
- Company-paid Life, Short-Term, and Long-Term Disability Insurance.
- Medical, Dental & Vision insurances
- FSA, DCARE, Commuter Benefits
- Supplemental Life, Hospital, Critical Illness and Legal Insurance
- Health Savings Account
- 401(k) Retirement Plan (Employer Matching benefit)
- Paid Time Off (Rollover Option) and Holidays
- As Needed Sick Time
- Tuition Reimbursement
- Team Social Activities (We have fun!)
- Employee Recognition
- Employee Referral Program
- Paid Parental Leave and Bereavement
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What This Job Offers
Job Type
Full-time
Career Level
Senior
