Process Development Engineer
About The Position
We are seeking a detail-oriented and proactive Process Development Engineer to translate new laboratory-scale chemical processes into safe, executable manufacturing instructions for scale-up within a small molecule API production facility. The role includes leading kilo lab or plant processing, coordinating cross-functional production support, and troubleshooting directly on the production floor. The engineer works closely with chemists to understand new processes, prepare batch records, guide operators through initial production, and adapt processes when they do not scale as expected. The position also oversees processing execution, supports technical compliance, develops processing and safety documentation, and collaborates with Chemistry, Quality, Operations, vendors, contractors, and clients. Additional duties include resolving process deviations and scaling issues, providing technical updates to clients, and supporting the maintenance, optimization, and upkeep of pilot plant equipment and infrastructure.
Requirements
- B.S. or M.S. in Chemical Engineering, or B.S. or M.S. in Chemistry with relevant plant experience.
- Strong foundational knowledge of chemical process scale-up, mass and energy balances, process safety management, and technical document authoring.
- Effective time management and ability to multitask, self-manage assigned work, and drive projects to completion.
- Ability to work effectively in a multidisciplinary team environment.
Nice To Haves
- Two or more years of relevant chemical processing or plant experience is preferred.
- Experience operating within a regulated cGMP environment is a distinct plus.
Responsibilities
- Work with chemists to understand new chemical processes and translate them into executable batch records and instructions.
- Scale production processes from laboratory scale to the kilo lab or plant, troubleshooting and adapting techniques as needed.
- Guide operators through initial production and oversee processing execution on the production floor.
- Review executed batch records for technical compliance.
- Author, review, and organize batch records, deviations, material specifications, hazard sheets, air emissions data, and processing reports.
- Conduct process safety meetings, develop safety review packages, and ensure scaling activities comply with plant safety protocols.
- Coordinate with Chemistry, Quality, and Operations throughout production, and manage interactions with vendors and contractors.
- Investigate and resolve process deviations or scaling anomalies on the shop floor.
- Host client project-status updates, provide tech transfer summaries, and communicate technical milestones.
- Provide chemical engineering support for pilot plant equipment and infrastructure maintenance, optimization, and upkeep.
