Process Engineer II - Tech Transfer & Validation Lead

Repligen Corporation; Marlborough (MA); Presencial; USD 85.000 - 120.000; Jornada completa

Descripción de la vacante

Repligen Corporation is seeking a Process Engineer to join the Proteins and Chromatography network in Marlborough, MA. You will lead tech transfer of chemical manufacturing processes, execute IQ/OQ/PQ, and drive validations along with future scale‑up and process optimization.

You will generate process flow diagrams, mass and energy balances, and support safety and quality risk assessments (FMEA, HAZOP). Collaboration across functions is essential.

Formación

• Bachelor's degree in Chemical Engineering or related field.
• 5+ years in chemical manufacturing.
• Experience with process equipment validation and tech transfer.
• Familiarity with ISO standards, cGMP, risk assessments and change control.

Responsabilidades

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

Conocimientos

Tech transfer leadership

IQ/OQ/PQ

Process validation

cGMP

ISO standards

FMEA / risk assessments

Lean Six Sigma

Cross-functional collaboration

Data-driven decision making

Educación

Bachelor's degree in Chemical Engineering

Descripción del empleo

Repligen Corporation is seeking a Process Engineer to join the Proteins and Chromatography network in Marlborough, MA. You will lead tech transfer of chemical manufacturing processes, execute IQ/OQ/PQ, and drive validations along with future scale‑up and process optimization.

You will generate process flow diagrams, mass and energy balances, and support safety and quality risk assessments (FMEA, HAZOP). Collaboration across functions is essential.