Process Engineer II

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

Job summary

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.

Responsibilities

• 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.

Skills

Safety culture

Process validation

ISO standards

FMEA

cGMP

Six Sigma

Cross-functional comms

Statistical tools

Education

Bachelor's in Chemical Engineering

Job description

We 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 $85,000-$120,000. 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.