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Lead Facilities Engineer
2 months ago
The Senior Facilities Engineer plays a pivotal role in delivering engineering, qualification, and maintenance support for both GMP and non-GMP utilities, HVAC, and electrical systems. This position is essential for ensuring the operational efficiency of the facility.
Key Responsibilities
- Assume ownership of site-based utility, electrical, and HVAC systems, including:
- Water-for-injection systems
- Chillers and boilers
- Compressed gases and plant steam
- Wastewater management
- Air handling units and clean rooms
- Provide hands-on support for the installation, maintenance, troubleshooting, and repair of facility assets.
- Manage changes to facility and utility equipment to ensure compliance with validation standards.
- Create, review, and approve critical documentation such as operational procedures and maintenance plans.
- Lead investigations into non-conformance events and alarm management processes.
- Develop engineering solutions for complex equipment-related issues.
- Participate in audits and respond to observations to maintain quality standards.
- Provide subject matter expertise throughout all project phases, ensuring compliance and operational excellence.
- Collaborate with cross-functional teams to drive continuous improvement initiatives.
Qualifications & Experience
- Bachelor’s degree in Chemical, Electrical, or Mechanical Engineering, or a related technical field, with a minimum of 8 years of relevant experience in the pharmaceutical or biotechnology sectors.
- Alternatively, an associate degree with 10 years of experience or equivalent work experience (12 years) may be considered.
- Strong communication skills, both oral and written, with an emphasis on technical writing.
- Proven ability to manage projects effectively from inception to completion.
- Familiarity with cGMP, GxP, and related regulations is essential.
- Proficient in Microsoft Office Suite and capable of learning new software systems.
- Strong interpersonal skills and the ability to work in a diverse team environment.
Additional Information
This role requires a commitment to operational excellence and the ability to adapt to evolving manufacturing processes. The successful candidate will demonstrate a proactive approach to problem-solving and a dedication to maintaining high standards of quality and compliance.