Process Engineer II

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

Process Engineer II# Careers## Process Engineer IIApply: Marlborough, MA: Full time: Posted Today: R-825We are on the lookout for a process engineer who will be a key member of the Proteins and Chromatography network here at Repligen. We are a life sciences company focused on the development, production and commercialization of high-value consumable products used in the process of manufacturing biological drugs. We are seeking an energetic individual with strong communication, leadership, technical and operational skills to join our highly motivated and collaborative team. This engineering role will focus on tech transfer of a chemical manufacturing process. They will lead equipment and process validations along with future process optimization and scale up.**Essential Job Functions*** Lead installation, operational qualifications of process equipment and process validations (IQ/OQ/PQ) to support NPI & Tech transfers* Support new chemical processes by generating process flow diagrams, mass & energy balances, along with safety (HAZOP) & quality risk assessments (FMEA)* Lead the development and execution of work instruction* Provide technical support for process deviations including investigation and corrective actions* Drive process improvements through data-based decisions* Promote safety & quality culture**Skills and Competencies*** Safety first mindset* Knowledge of process/equipment validation* Strong understanding of ISO standards, risk assessments, deviation investigations and change control* Knowledge of Good Manufacturing Practices (cGMP)* Understanding of statical tools and statical process control* Lean manufacturing & Six Sigma knowledge are a plus* Strong communication skills and ability to work with cross functional teams**Work Environment*** The Process Engineer will be required to perform duties on a computer, in an office environment and on the production floor. The employee will be required to work closely with employees on the manufacturing floor and in other departments. Travel will be required as part of the role**Required Education and Experience*** Bachelor's degree or higher in Chemical Engineering or related field* 5+ years of experience in related field, with experience in chemical manufacturing*Our mission is to inspire advances in bioprocessing as a trusted partner in the production of biologic drugs that improve human health worldwide. Focused on cost and process efficiencies, we deliver innovative technologies and solutions that help set new standards in bioprocessing. The estimated salary range for this role, based in the United States of America is $100,000-$130,000. Compensation decisions are dependent on several factors including, but not limited to an individual's qualifications, location, internal equity, and alignment with market data. Additionally, employees are eligible to participate in one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits such as paid time off, health/dental/vision, retirement benefits and flexible spending accounts. All compensation and benefits information will be confirmed in writing at the time of offer.*