Seeking a Facilities Engineer II to support the reliable operation, maintenance, and continuous improvement of utility and facility infrastructure supporting Quality Control Laboratories. This role focuses on HVAC, water systems, electrical distribution, and other mission-critical utilities while ensuring compliance with cGMP, FDA regulations,
Key Responsibilities
Utility Systems Ownership & Reliability
- Oversee performance, capacity, and reliability of:
- HVAC systems
- RODI (Reverse Osmosis Deionized Water)
- Purified Water (PW)
- Heating and chilled water systems
- Electrical distribution systems
- Ensure utility systems operate within validated parameters.
- Provide on-call support for utility-related issues as needed.
Compliance & Quality
- Maintain compliance with cGMP, FDA regulations, safety standards, and Pfizer policies.
- Own and maintain utility system documentation, maintenance records, deviations, and change controls.
- Participate in regulatory inspections, audits, and internal quality reviews.
- Support deviation investigations, impact assessments, and CAPA implementation.
Maintenance & Continuous Improvement
- Develop and update SOPs, work instructions, and maintenance schedules.
- Collaborate with Maintenance and EH&S teams to ensure system reliability.
- Monitor system performance and consumption trends.
- Identify opportunities for:
- Predictive maintenance
- Energy efficiency improvements
- Cost reduction
- Reliability enhancements
Troubleshooting & Technical Support
- Lead or support root cause investigations for utility system failures.
- Implement corrective and preventive actions (CAPAs).
- Provide technical guidance and training for operations and maintenance personnel.
- Troubleshoot complex facility and utility system issues.
Projects & Engineering Support
- Manage small to medium-sized utility and facilities projects.
- Support commissioning, qualification, and startup activities for new or modified utility systems.
- Provide technical input on facility and utility design, installation, and upgrades.
- Mentor junior engineers and technicians when needed.
Cross-Functional Collaboration
- Partner with:
- Manufacturing
- Quality
- Facilities
- Maintenance
- Drive operational excellence across site infrastructure and utilities.
Required Qualifications
Education
Bachelor's Degree in Mechanical, Electrical, Chemical Engineering, or related field AND
OR
Master's Degree in Mechanical, Electrical, Chemical Engineering, or related field
- Experience supporting utility systems in:
- Pharmaceutical
- Biotechnology
- Mission-critical facilities
- Strong understanding of cGMP environments
- Water purification and utility system knowledge
- Maintenance planning and scheduling experience
- Root cause analysis and troubleshooting skills
- Strong technical problem-solving abilities
- Excellent communication and teamwork skills
- Proficiency with Microsoft Office
Preferred Qualifications
- Certified Energy Manager (CEM)
- Commissioning, qualification, and validation experience
- Deviation investigations and technical writing experience
- Predictive maintenance expertise
- Lean manufacturing experience
- Support pharmaceutical and laboratory facilities.
- Ability to work in aseptic/gowned environments.
- Occasional weekend work and travel may be required.
- Physical requirements include standing, walking, bending, lifting, and performing engineering calculations.