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.
Skills Required
- Bachelor's degree or higher in Chemical Engineering or a related field
- 5 or more years of experience in a related field
- Experience in chemical manufacturing
- Knowledge of process and equipment validation
- Understanding of ISO standards, risk assessments, deviation investigations, and change control
- Knowledge of current Good Manufacturing Practices (cGMP)
- Understanding of statistical tools and statistical process control
- Lean manufacturing and Six Sigma knowledge
- Strong communication skills and ability to work with cross-functional teams
What We Do
FRAUD ALERT: Please take note that it has come to our attention that individuals purporting to work for Repligen are reaching out to prospective job applicants using fraudulent email addresses. All legitimate communications from Repligen will be sent from an individual with an email address ending in @repligen.com. If you have any concerns that a communication may be fraudulent and you would like to confirm whether it is, you may email [email protected] and someone will respond. Repligen is a bioprocessing-focused life sciences company bringing over 40 years of expertise and innovation to our customers. We are inspiring advances in bioprocessing through the development and commercialization of high-value products and flexible solutions that address critical steps in the production of biologic drugs, principally monoclonal antibodies. Repligen headquarters is in Waltham, Massachusetts and our manufacturing facilities are located around the world. We market our products globally through a direct commercial organization in the U.S., Europe and Asia, as well as through strategic partners in select markets.
