Engineer II, Facilities
About The Position
About This Role The Engineer II, Facilities role focuses primarily on temperature-controlled chambers and supports validation activities across the manufacturing facility. You’ll work closely with Facilities, Utilities, Manufacturing, Quality, and Engineering teams to ensure GMP assets are properly commissioned, qualified, and maintained. What You’ll Do Support validation and qualification activities for temperature-controlled chambers and related GMP equipment Assist with the development and execution of IQ/OQ/PQ protocols under guidance from senior engineers Participate in commissioning and qualification of new and existing equipment Support Facilities operations by helping troubleshoot equipment issues and identifying improvement opportunities Assist with change controls, deviations, and CAPAs in a GMP-regulated environment Collaborate with cross-functional teams including Facilities, Utilities, Manufacturing, Quality, and Maintenance Lead small projects and continuous improvement initiatives, gaining exposure to project management fundamentals Maintain accurate documentation, training records, and compliance workflows Learn and apply GMP regulations and site standards to daily engineering activities Who You Are You are highly motivated and eager to learn, with a strong interest in building technical expertise within a GMP-regulated manufacturing environment. You are excited by hands-on validation work and value opportunities to contribute to projects, process improvements, and cross-functional initiatives. You view this role as a foundation for long-term growth and are driven to expand your knowledge across multiple areas of Engineering and Validation while consistently delivering results.
Requirements
- Bachelor’s degree in Engineering
- Proven ability to follow procedures, document work clearly, and manage multiple tasks
- Understanding of FDA cGMP regulations
- Interest in equipment validation and GMP compliance
- Proficiency with Microsoft Word, Excel, and PowerPoint
- Strong written and verbal communication skills
- Willingness to occasionally support extended hours or weekend work, as needed
Nice To Haves
- 0 – 1 year of relevant experience in biotech or adjacent industry
- Exposure to temperature-controlled chambers or utility systems
- Internship, co-op, or early-career experience in biotechnology or pharmaceutical manufacturing
- Familiarity with IQ/OQ/PQ documentation
- Experience or interest in project management or process improvement
- Exposure to validation tools such as Kaye or LIVES data loggers
- Experience supporting deviations, investigations, or change controls
Responsibilities
- Support validation and qualification activities for temperature-controlled chambers and related GMP equipment
- Assist with the development and execution of IQ/OQ/PQ protocols under guidance from senior engineers
- Participate in commissioning and qualification of new and existing equipment
- Support Facilities operations by helping troubleshoot equipment issues and identifying improvement opportunities
- Assist with change controls, deviations, and CAPAs in a GMP-regulated environment
- Collaborate with cross-functional teams including Facilities, Utilities, Manufacturing, Quality, and Maintenance
- Lead small projects and continuous improvement initiatives, gaining exposure to project management fundamentals
- Maintain accurate documentation, training records, and compliance workflows
- Learn and apply GMP regulations and site standards to daily engineering activities
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
