Process Engineer II

RepliGen Corporation • Marlborough, MA

2d • $100,000 - $130,000

About The Position

Repligen is seeking an energetic Process Engineer to join its Proteins and Chromatography network. The company develops, produces, and commercializes high-value consumable products used in the manufacture of biological drugs. This engineering role focuses on technology transfer of a chemical manufacturing process, including leading equipment and process validations and supporting future process optimization and scale-up. The role works with manufacturing-floor employees and other departments, and requires travel.

Requirements

• Bachelor's degree or higher in Chemical Engineering or a related field.
• At least 5 years of experience in a related field, including experience in chemical manufacturing.
• Safety-first mindset.
• Knowledge of process and equipment validation.
• Strong understanding of ISO standards, risk assessments, deviation investigations, and change control.
• Knowledge of Good Manufacturing Practices (cGMP).
• Understanding of statistical tools and statistical process control.
• Strong communication skills and ability to work with cross-functional teams.

Nice To Haves

• Knowledge of Lean manufacturing and Six Sigma.

Responsibilities

• Lead installation and operational qualifications of process equipment and process validations (IQ/OQ/PQ) to support new product introductions and technology transfers.
• Support new chemical processes by generating process flow diagrams and mass and energy balances, as well as safety (HAZOP) and quality risk assessments (FMEA).
• Lead the 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 a safety and quality culture.

Benefits

• Paid time off.
• Health, dental, and vision benefits.
• Retirement benefits.
• Flexible spending accounts.
• Eligible employees may participate in a variable cash program (bonus or commission).
• Eligible roles may receive equity as part of the compensation package.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level