Process Engineering Leadership
About the Role:
The Process Engineering Lead will oversee the development and implementation of manufacturing process recipes, facility layouts, and equipment configurations for new product introductions and process upgrades. This position requires expertise in designing, modifying, and optimizing upstream and downstream processes.
Main Responsibilities:
* Manage the creation, maintenance, and revision of manufacturing process recipes, ensuring alignment with business objectives.
* Accountable for delivering high-quality technical documentation, including protocols, reports, and SOPs to support manufacturing processes.
* Collaborate with cross-functional teams to evaluate process equipment and controls, identifying opportunities for improvement.
* Contribute to continuous improvement initiatives, action plans to implement operational excellence, and lean practices, setting and maintaining departmental goals and metrics.
Key Requirements:
* Proven experience in designing, modifying, and optimizing upstream and downstream processes steps.
* Experience in troubleshooting and optimizing manufacturing processes for efficiency and effectiveness.
* Familiarity with Delta-V, Unicorn, or other Manufacturing Automation systems.
* Bachelor's or Master's degree in a relevant discipline (e.g., biochemistry, chemistry, process engineering) or equivalent experience.
* Background in pharmaceutical manufacturing organizations and/or bioprocess development, with experience in upstream unit operations, process scale-up, facility layout, and process validation.