Facilities Engineer
- Facilities and Utilities Management:
- Support and monitor preventive maintenance (PM) programs for facility and utility systems to ensure reliability and compliance.
- Support calibration and qualification activities related to facility and utility systems.
- Regulatory Compliance & Documentation:
- Ensure facilities meet FDA, GMP, and other regulatory requirements.
- Maintain accurate and complete engineering and maintenance documentation including equipment files, change controls, deviation reports, and CAPAs.
- Update/Develop Facility Related to QWI’s and QOP’s
- Generate/Close Change Controls, Investigations, and CAPAS related to the Facilities GMP requirements
- Serve as SME for SAP related activities and provide training to facilities personnel
- Serve as a liaison between QA and Facilities
- Participate in internal and external audits and inspections; provide documentation and responses as needed.
- Project Engineering:
- Lead or support capital projects for facility upgrades, expansions, or equipment installations.
- Support creation of user requirements, design specifications, and validation protocols.
- Manage contractors, vendors, and service providers to ensure safe and compliant work execution.
- Environmental Health & Safety (EHS):
- Support compliance with local, state, and federal safety regulations.
- Conduct risk assessments and implement corrective and preventive measures to maintain a safe workplace.
- Continuous Improvement:
- Identify and implement process improvements to enhance facility efficiency, sustainability, and reliability.
- Support lean manufacturing and energy conservation initiatives
- Performs other related duties as assigned.
- Associate’s degree in engineering (Mechanical, Electrical, Chemical, or related field), at a minimum
- 2–5 years of experience in facilities or utilities engineering, preferably in an FDA-regulated (pharmaceutical, medical device, or biotech) environment.
- Strong knowledge of cGMP, FDA, and ISO 13485 regulations.
- Experience with cleanroom environments, HVAC design, and critical utility systems preferred.
- Proficiency with CMMS systems and building automation systems (BAS/BMS).
- Excellent problem-solving, troubleshooting, and project management skills.
- Strong written and verbal communication skills
- Competitive compensation package
- Modern working environment with state-of-the-art facilities and technologies
- Challenging assignments in a fast growing and innovative industry
- Position in a dynamic, international team of highly skilled professionals
- Various opportunities for personal and professional development within a global organization
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