6577 - Senior Process Engineer

Verista; Madison (WI); On-site; USD 74,000 - 118,000; Full time

Benefits offered by this job

Growth potential

Incentive programs

Life insurance

Medical insurance

Dental insurance

Vision insurance

401(k) matching

Paid time off

Tuition reimbursement

Team events

Employee recognition

Paid parental leave

Bereavement leave

Job summary

Verista is seeking an experienced Senior Process Engineer – MSAT to support GMP biologics drug substance manufacturing. You will lead technology transfer from development to manufacturing, support scale-up, optimization, and process design while maintaining MBRs and manufacturing documentation.

The role requires strong upstream/downstream biologics experience, GMP knowledge, and excellent client-facing communication skills to ensure successful process execution and readiness.

Qualifications

• Bachelor's degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field.
• Experience in MSAT, process engineering, or process development within biologics manufacturing.
• Strong knowledge of GMP biologics drug substance manufacturing and quality systems.

Responsibilities

• Serve as SME supporting GMP biologics drug substance manufacturing.
• Lead technology transfer activities from process development to manufacturing.
• Support process development, scale-up, optimization, and process design.
• Develop and maintain Master Batch Records (MBRs) and manufacturing documentation.
• Provide technical expertise for upstream and/or downstream biologics manufacturing operations.
• Support deviation investigations, CAPAs, change controls, and other QMS activities.
• Evaluate CQAs, CPPs, QTPPs and process parameters.
• Troubleshoot manufacturing issues and implement improvements.
• Collaborate with Manufacturing, Quality, Engineering and clients for successful execution.
• Support process characterization, validation and manufacturing readiness.

Skills

MSAT

Technology transfer

GMP knowledge

Scale-up

Master Batch Records

Biologics manufacturing

Upstream/downstream

Client-facing

Process optimization

Troubleshooting

Education

Bachelors in Chemical/Biochemical Engineering or Biotechnology

Job 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

• 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.

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.

Preferred Qualifications

• 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.

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.

National (US) Range: $73,920 USD - $118,062 USD

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