- Location
- Madison, WI · Fishers, Indiana, United States
- Department
- CQV Manufacturing
- Seniority
- Senior
- Education
- Bachelor
- Source
- Greenhouse
Description
Description
Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.
Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.
Company Culture Guidelines & Values:
- We empower and support our colleagues
- We commit to client success at every turn
- We have the courage to do the right thing
- We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
- We constantly acquire new skills and learn from our experiences to enhance our collective expertise
We are 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.
Senior Process Engineer Responsibilities:
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Serve as a technical Subject Matter Expert (SME) supporting GMP biologics drug substance manufacturing.
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Lead technology transfer activities from process development and external clients into manufacturing.
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Support process development, scale-up, optimization, and manufacturing process design.
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Develop, review, and maintain Master Batch Records (MBRs) and manufacturing documentation.
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Provide technical expertise for upstream and/or downstream biologics manufacturing operations.
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Support deviation investigations, impact assessments, CAPAs, change controls, and other QMS activities.
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Evaluate process parameters, CQAs, CPPs, and Quality Target Product Profiles (QTPPs).
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Troubleshoot manufacturing issues and implement process improvements.
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Collaborate with Manufacturing, Quality, Engineering, and external clients to ensure successful process execution.
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Support process characterization, validation, and manufacturing readiness activities.
Requirements:
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Bachelor's degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related discipline.
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Experience in MSAT, process engineering, or process development within biologics manufacturing.
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Strong technology transfer experience supporting GMP biologics drug substance manufacturing.
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Hands-on knowledge of upstream and/or downstream manufacturing processes.
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Experience with process scale-up, process design, and manufacturing optimization.
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Experience developing or reviewing Master Batch Records and GMP documentation.
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Knowledge of QTPPs, CQAs, CPPs, and biologics process development.
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Experience with GMP quality systems, including deviations, CAPAs, change controls, and impact assessments.
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Excellent communication, interpersonal, and client-facing skills.
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Ability to work independently and provide technical expertise with minimal training.
Preferred Qualifications:
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Previous MSAT experience within a CDMO environment.
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Experience with both upstream and downstream biologics operations.
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Experience with bioreactors, cell culture, chromatography, filtration, or UF/DF.
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Experience supporting process characterization, PPQ, and process validation.
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Direct experience managing client-facing technology transfer activities.
For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.
*Verista is an equal opportunity employer.
Benefits
Why Choose Verista?
- 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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For more information about our company, please visit us at Verista.com