Process Engineer II

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

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

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.

Benefits

• paid time off
• health/dental/vision
• retirement benefits
• flexible spending accounts

All compensation and benefits information will be confirmed in writing at the time of offer.

Thank you for your interest in Repligen! Working at Repligen means being part of a team that is excited to find new and creative ways to overcome challenges in bioprocessing - and to help our customers make a difference in the world.