Senior MSAT Process Engineer – Biologics Tech Transfer

Verista; Madison (WI); In loco; USD 74.000 - 118.000; Tempo pieno

Vantaggi offerti da questo lavoro

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

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

MSAT

Technology transfer

GMP knowledge

Scale-up

Master Batch Records

Biologics manufacturing

Upstream/downstream

Client-facing

Process optimization

Troubleshooting

Formazione

Bachelors in Chemical/Biochemical Engineering or Biotechnology

Descrizione del lavoro

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.