Process Engineer II: Bioprocess Tech Transfer & Validation

Repligen Corporation; Marlborough (MA); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Flexible spending accounts

Job summary

Repligen Corporation in Marlborough, MA is seeking a Process Engineer II to join the Proteins and Chromatography network. You will lead tech transfer of chemical manufacturing processes, oversee IQ/OQ/PQ validations, and collaborate across manufacturing, quality, and engineering to ensure robust scale-up and reliable product supply.

The role emphasizes data-driven process improvements, risk assessments, and adherence to cGMP standards.

Qualifications

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

Responsibilities

• Lead IQ/OQ/PQ validations for process equipment.
• Support NPI & Tech transfers with process diagrams and mass/energy balances.
• Lead development and execution of work instructions.
• Investigate deviations and implement corrective actions.
• Drive process improvements using data-driven decisions.
• Promote safety and quality culture.

Skills

Process validation

IQ/OQ/PQ

Risk assessment

Change control

cGMP

Data analysis

Lean manufacturing

Six Sigma

Cross-functional

Project leadership

Education

Bachelors in Chemical Engineering

Tools

None

Job description

Repligen Corporation in Marlborough, MA is seeking a Process Engineer II to join the Proteins and Chromatography network. You will lead tech transfer of chemical manufacturing processes, oversee IQ/OQ/PQ validations, and collaborate across manufacturing, quality, and engineering to ensure robust scale-up and reliable product supply.

The role emphasizes data-driven process improvements, risk assessments, and adherence to cGMP standards.