Senior Utilities Engineer
DSJ Global is currently partnered with an award winning and fast-growing pharmaceutical manufacturing company who is looking to add a Senior Utilities Engineer to their team in Lenior, NC. This role is the site Subject Matter Expert (SME) for site GMP Clean Utilities infrastructure and systems (WFI, Clean Steam, Pharmaceutical/Oil-Free Compressed Air, Process Gases, HVAC, etc.) and applications in aseptic manufacturing. The role also has specific responsibility to participate over cross functional site improvements (design, construction, commissioning, qualification and start-up) of all GMP Utilities as well as closely monitoring the existing systems with respect to quality of final product and efficiency of operation.
Responsibilities will include:
- Strong technical skills, be the Subject Matter Expert (SME) from equipment Utilities-HVAC systems. Deep technical expertise in all systems under his/her responsibility (GMP Utilities and ancillary systems associated within their facilities) and understanding their applications in pharmaceutical aseptic manufacturing.
- You will provide technical SME support for mechanical, electrical, and pneumatic improvements or changes that impact utilities or utilities maintenance.
- Support clean-black utilities equipment installation, qualification, start-up, PMs and coordinate vendors support as required.
- Develop and modify procedures as needed to support clean-black utilities and HVAC systems.
- Participate in clean utilities validation activities during project life cycle.
- You will lead or support overall compliance requirements for the Utilities areas, including SOPs, change control, quality investigations and CAPAs.
- Support utilities areas in Regulatory / FDA inspections ensuring successful outcomes.
- Ensure that all work is performed in accordance with standard operating procedures (SOPs), Current Good Manufacturing Practices (cGMP), safety procedures, quality standards, Occupational Safety and Health Administration (OSHA) standards, other regulatory agency standards, and good maintenance practices.
Qualifications
- Bachelors degree in Engineering with at least 5 years of experience OR Masters with more than 3 year of experience.
- Engineering experience in the Pharmaceutical, Biotech or Medical Device industries.
- Experience in WFI and HVAC systems, clean and black utilities both design and operations.
- Experience with maintenance, reliability, and computerized maintenance management systems (CMMS)
- Hands-on experience in equipment upgrades and integration of new technology to improve plant facilities / central utilities operations.
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