Tech Transfer Engineer II - Bioprocessing

Repligen Corp; Marlborough (MA); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Paid time off

Health/dental/vision

Retirement benefits

Flexible spending accounts

Job summary

Repligen Corp is seeking a Process Engineer to join the Proteins and Chromatography network in Marlborough, MA. The role focuses on tech transfer of chemical manufacturing processes and leading IQ/OQ/PQ validations, while driving future scale-up and optimization.

Responsibilities include developing process documentation, supporting deviations with investigations, and applying data-driven decisions to improve safety, quality, and efficiency. Travel may be required.

Qualifications

• Bachelor's degree in Chemical Engineering or related field with 5+ years of chemical manufacturing experience.
• Experience supporting tech transfers, IQ/OQ/PQ, and process validations.
• Knowledge of ISO standards, risk assessments, deviation investigations and change control.
• Strong understanding of cGMP and quality systems.
• Lean/Six Sigma knowledge is a plus; strong communication across functions.

Responsibilities

• Lead IQ/OQ/PQ for process equipment and support NPIs and tech transfers.
• Create process flow diagrams and mass/energy balances with safety and quality risk assessments.
• Develop and execute work instructions.
• Investigate deviations and implement corrective actions.
• Drive process improvements using data-driven decisions.
• Promote safety and quality culture on the shop floor.

Skills

Safety mindset

Process validation

ISO risk & change control

cGMP knowledge

Statistical process control

Lean Six Sigma

Cross-functional communication

Education

Bachelor's degree in Chemical Engineering or related field

Job description

Repligen Corp is seeking a Process Engineer to join the Proteins and Chromatography network in Marlborough, MA. The role focuses on tech transfer of chemical manufacturing processes and leading IQ/OQ/PQ validations, while driving future scale-up and optimization.

Responsibilities include developing process documentation, supporting deviations with investigations, and applying data-driven decisions to improve safety, quality, and efficiency. Travel may be required.