Process Engineer

Main Responsibilities / Key Accountabilities
- Serve as a Subject Matter Expert (SME) supporting Manufacturing, Engineering, and Capital Projects (drug substance focus).
- Develop process equipment concepts/scope; specify and design process equipment.
- Manage equipment vendors to meet requirements, cost, and schedule.
- Develop and execute commissioning and qualification (CQ) documentation.
- Lead equipment start-ups, optimization, and provide knowledge transfer at project close.
- Support routine process equipment activities; troubleshoot complex system issues to minimize downtime.
- Partner with Maintenance, Operations, Engineering, Quality, and Continuous Improvement during design.
- Interface with Operations to ensure equipment meets production requirements; provide input to quality and safety systems.
- Identify and implement process improvements to enhance efficiency, safety, and quality.

Basic Qualifications
- BS in Engineering (Chemical preferred; other engineering disciplines accepted).
- 4+ years process engineering experience in life sciences and/or vaccine manufacturing.
- Drug substance process knowledge focused on process equipment, automated mechanical systems, and instrumentation.
- Strong analytical skills; hands-on troubleshooting.
- Knowledge of pharmaceutical processes and GMP regulatory requirements (including CQ activities).
- Strong organizational, written, and oral communication.

Desired Qualities / Experiences
- Lead small projects; equipment system lead experience.
- Understanding of utilities impact; cost/schedule/scope management.
- Automation design/testing knowledge; FAT, SAT, and start-up experience.

Benefits (explicit)
- Health and wellbeing benefits and at least 14 weeks’ gender-neutral parental leave.