Overview
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.
Responsibilities
As Process Engineer III you will be responsible for the following:
- Lead installation, operational qualifications of process equipment and process validations (IQ/OQ/PQ)
- 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
- Some travel will be required
Qualifications
Required Education and Experience
- Bachelor's degree or higher in Chemical Engineering or related field
- 5-8+ years of experience in related field, with experience in chemical manufacturing
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
What Repligen Offers
Repligen offers you a competitive remuneration package, including a yearly bonus and flexible working hours. But most importantly Repligen offers you a stimulating environment with a steep learning curve and the opportunity to contribute to the healthcare of patients worldwide. All of this with an international team and a modern office in Ravensburg, Germany.
