Senior Process Development Engineer

Olon USA • Concord, OH

7d

About The Position

We are seeking a detail-oriented and proactive Senior Process Development Engineer to translate laboratory-scale chemical processes into safe, executable manufacturing instructions for scale-up within a small molecule API production facility. The role involves adapting across kilo lab, plant, and HPAPI production areas and providing guidance to other team members.

The engineer will work closely with chemists to understand new processes, prepare batch records, guide operators through initial production, and scale processes from laboratory to kilo lab or plant infrastructure. They will support HPAPI production as the site's subject matter expert, oversee processing, participate on the production floor as appropriate, and review executed batch records for technical compliance.

The position also includes authoring and reviewing processing documentation, conducting process safety meetings, supporting compliance with plant safety protocols, troubleshooting process deviations and scale-up issues, and collaborating with Chemistry, Quality, Operations, vendors, contractors, and clients. The engineer will provide client status updates and technical summaries, and support maintenance, optimization, and upkeep of pilot plant equipment and infrastructure.

Requirements

• B.S. or M.S. in Chemical Engineering or Chemistry.
• Ten or more years of experience in scale-up or preparation of pharmaceutical and specialty chemicals.
• Strong foundational knowledge of chemical process scale-up, mass and energy balances, and process safety management.
• Experience or capability in technical document authoring.
• Effective time management and a strong multitasking mindset to self-manage assigned tasks and drive projects to completion.
• Ability to work effectively in a multidisciplinary team environment.

Responsibilities

• Work closely with chemists to understand new chemical processes and translate them into executable instructions, including batch records.
• Guide operators through initial production.
• Learn and scale production processes from laboratory scale to kilo lab or plant infrastructure.
• Troubleshoot and adapt processes when small molecule techniques do not scale as expected, and assist other engineers with challenging scale-up situations.
• Support HPAPI production processes and serve as the site's subject matter expert.
• Oversee processing, participate on the production floor as appropriate, and review executed batch records for technical compliance.
• Author, review, and organize processing documentation, including 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 adhere to plant safety protocols.
• Collaborate with Chemistry, Quality, and Operations throughout production, and manage external interactions with vendors and contractors.
• Investigate and resolve process deviations or scaling anomalies on the shop floor using development troubleshooting and problem-solving skills.
• Host regular project status updates for clients, deliver tech transfer summaries, and communicate technical milestone progress.
• Provide day-to-day chemical engineering support for maintenance, optimization, and upkeep of pilot plant equipment and infrastructure.
• Provide guidance to other team members.

What This Job Offers

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