The Utilities Engineer will be responsible for leading the GMP Utilities systems design, fabrication, installation, and commissioning for a newly announced facility expansion that includes a dedicated high-speed cartridge filling line, significant utilities upgrade, dedicated formulation and processing suites, with Clean In Place (CIP) and Sanitize In Place (SIP) capabilities. Working closely with system owners and related stakeholders this role will lead the utilizes area capacity expansion. Serves as subject matter expert for all GMP Utilities: Water for Injection (WFI), Clean Steam (CS), Instrument and Cleaned Compressed air systems, and process gas generation and distribution.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Support design, installation, acceptance testing, training activities, etc. ensuring all facilities and utilities systems adhere to pharmaceutical industry regulations and standards.
- Troubleshoot and perform risk assessments for utilities systems to ensure safe installation, operation, and maintenance of utilities systems and equipment.
- Maintain comprehensive documentation of maintenance activities, compliance records, and equipment specifications.
- Coordinate with cross-functional teams, contractors, and vendors to meet project goals.
MINIMUM QUALIFICATIONS (KNOWLEDGE, SKILLS, AND ABILITIES)
- Bachelor’s degree in engineering or relevant sciences and 7+ years of experience with GMP Utilities.
- 5 years’ experience with sterile injectables, combo-devices, or biologics.
- Start-up experience preferred.
- Advanced degrees or certification relevant to the role is a plus.
- Ability to think strategically and tactically (detail-oriented)
- Strong collaborative and influencing skills, and ability to work well in a cross-functional, matrixed environment.
- Demonstrated ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
- Proven track record of being self-motivated and capable of working with cross-functional teams while remaining positive towards project challenges.