Process Transfer & Validation Engineer II - Equity Eligible

Repligen; Marlborough (MA); Sur place; USD 85 000 - 120 000; Plein temps

Résumé du poste

Repligen in Marlborough, MA seeks a Process Engineer to lead tech transfer and scale-up for chemical manufacturing. The role focuses on IQ/OQ/PQ validations, process optimization, and ensuring GMP compliance while supporting NPI and transfers.

You will generate process diagrams, safety analyses, and yield improvements, collaborating with cross-functional teams on deviations, root-cause investigations, and action plans. Travel to manufacturing sites is expected.

Qualifications

• Bachelor's degree in Chemical Engineering or related field.
• 5+ years of experience in chemical manufacturing.

Responsabilités

• Lead installation, IQ/OQ/PQ and process validations to support NPI and tech transfers.
• Support new chemical processes by generating process flow diagrams, mass and energy balances, and safety risk assessments (HAZOP & FMEA).
• Lead development and execution of work instructions.
• Provide technical support for process deviations including investigations and corrective actions.
• Drive process improvements through data-based decisions.
• Promote safety and quality culture across the organization.

Connaissances

Safety culture

Process validation

ISO standards

FMEA

cGMP

Six Sigma

Cross-functional comms

Statistical tools

Formation

Bachelor's in Chemical Engineering

Description du poste

Repligen in Marlborough, MA seeks a Process Engineer to lead tech transfer and scale-up for chemical manufacturing. The role focuses on IQ/OQ/PQ validations, process optimization, and ensuring GMP compliance while supporting NPI and transfers.

You will generate process diagrams, safety analyses, and yield improvements, collaborating with cross-functional teams on deviations, root-cause investigations, and action plans. Travel to manufacturing sites is expected.