Senior Utilities Engineer

As a Sr Utilities Engineer (Clean Utilities), you will provide cross-functional support to operations, maintenance, quality and project teams for site GMP utilities. You will be setting priorities, forecasting, and identifying resources needed to make improvement to existing systems as needed.   

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. In addition, the ancillary systems associated within their facilities. It 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 the Production Operations in ensuring that utilities equipment is maintained to meet GMP requirements.
• Support utilities areas in Regulatory / FDA inspections ensuring successful outcomes.
• Cross functional collaboration with QC Micro, Operations, QA, Reliability, and other Engineering functional areas.
• 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.
• Support facilities, utilities, and infrastructure asset life-cycle replacement strategies and capital investment plans.
• Support to develop and write equipment specifications, user requirement specifications, performance requirements, cost analysis, capital projects, change controls, and proposal for integrating new machinery-utilities into the site.
• This site operates 24/7, and you may be required to provide engineering support to Plant operations 24/7 as needed (overall facilities, utilities, equipment, etc.).
• This is a key position, a technical advisor for the Engineering and Maintenance Department through teamwork and the formation of key alliances will drive, support, and implement key Plant projects and initiatives.
• Ensures adherence to company safety standards, policies, and procedures. Ensures maintenance staff and contractors correctly wears and uses safety equipment, as required.
• Also, ensures that all safety inspections are completed as required and ensures adherence to company EHS policies.

  
Qualifications
 

• Applicant must have a a 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)
• Engineering experience in a Facilities, Utilities, Maintenance, Project, or Plant Engineering roles.
• Self-starter and have a proven track record in pharmaceutical facilities, clean-black utilities, equipment maintenance and troubleshooting.
• Experience in large facility and campus facility management and maintenance of buildings, building equipment and infrastructure.
• Hands-on experience in equipment upgrades and integration of new technology to improve plant facilities / central utilities operations.
• Required a thorough understanding of the operational processes of an organization and have a truly multidisciplinary role, working closely with colleagues across several functions in the site, including operations, maintenance, instrumentation, reliability, procurement, quality, technical services, validation, and project engineering.
• Demonstrated ability to interact effectively with contract service partners.
• Effective written and verbal communication skills.
• Ability to update and maintain plant drawings of utility systems.