The Senior Clean Utilities Engineer is the Subject Matter Expert (SME) and provides engineering support to field personnel in the performance of maintenance and operational tasks associated with Clean Utilities, including reverse osmosis/electrodeionization (RO/EDI) skids, water for injection (WFI), purified water (WPU), Clean gasses and applicable waste systems. This role provides ownership for the assigned clean utility systems and partners with other stakeholders in the operation of owned systems. This role works directly with other Utility Engineers to ensure applicable safety and regulatory standards are maintained, identify process improvements, and assist with troubleshooting equipment issues to maintain overall plant reliability. Additionally, this role supports deviation investigations and mentors' other engineers, as needed across a spectrum of engineering disciplines.

What You’ll Do

•Spearheads the team within assigned discipline through activities (e.g., system startup and troubleshooting, maintenance and upgrades, specification review, Factory Acceptance Tests (FATs) and visits, equipment installation, and issue resolution) are performed to the company standards
•Develops Project Change Controls (PCCs) to document specific changes to the design of systems within assigned discipline
•Performs and provides guidance for deviations and change controls resolutions and closures
•Reviews submittals, installation, and testing of equipment within assigned discipline across all buildings onsite
•Performs field walkdowns with Utility Engineering and Construction personnel to ensure systems are installed per approved standards and drawings
•Reviews and approves Preventative Maintenance templates for equipment within assigned discipline
•Partners with Utility Operators and Maintenance Technicians to resolve operational issues
•Leads the development for User Requirements Specification (URS) and Standard Operating Procedures (SOPs), equipment maintenance and troubleshooting in assigned systems
•Contributes to the development for various test protocols and functional testing documents (e.g., installation qualification (IQ), operational qualification (OQ), etc.)
•Reviews equipment and system trends and provides recommendations to management for improvement
•Participates in the implementation of maintenance strategies to maximize equipment reliability
•Leads small teams through system design changes
•Maintains system and equipment maintenance requirements, schedules, and execution
•Maintains Good Manufacturing Practices (GMP) compliance aspects of validated systems
•Participates in audits with customer representatives and regulatory agencies
•Provides guidance and mentorship to junior Engineers, as needed
•Provides engineering technical support for all plant utilities and systems (e.g., plant steam boilers, cooling systems, compressed air, etc.)
•Communicates updates to site leadership on key technical efforts, strategic initiatives, and other relevant information
•Troubleshoots simple and complex system challenges and makes complex decisions across the site within assigned discipline
•Cross-trains on multiple disciplines to assist the larger Engineering team with achieving deliverables
•Collaborates with other departments (e.g., Utility Operations, Manufacturing, and Validation)
•Other duties, as assigned

Knowledge & Skills

•Knowledge of cGMP and European Medicines Evaluation Agency (EMEA) or Food & Drug Administration (FDA) regulations
•Effective communication, both written and verbal
•Proficient in Microsoft Office (e.g., Word, Excel, PowerPoint, SharePoint)
•Ability to analyze and troubleshoot simple to moderate system and component related issues
•Ability to coordinate and facilitate effective small cross-functional teams
•Ability to mentor and guide junior-level Engineers

Required Skills

•Bachelor’s degree in Engineering or related field with 8 years of experience with process utility systems and components in an industrial environment
•Experience working in a current Good Manufacturing Practices (cGMP) or other highly regulated environment

Preferred Skills

•Masters Degree in Engineering, Business Management, or related field with 6 years of experience with process utility systems and components in a cGMP environment or other highly regulated environment

Working Conditions & Physical Requirements:

PHYSICAL DEMANDS
Will work in environment which may necessitate respiratory protection. X No Yes
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. No X Yes
Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes
Ability to discern audible cues. No X Yes
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. No X Yes
WORKING ENVIRONMENT
PHYSICAL DEMANDS
Ability to ascend or descend ladders, scaffolding, ramps, etc. No X Yes
Ability to stand for prolonged periods of time. No X Yes 60 minutes
Ability to sit for prolonged periods of time. No X Yes 240 minutes
Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. X No Yes
Ability to operate machinery and/or power tools. No X Yes
Ability to conduct work that includes moving objects up to X pounds. No X Yes If yes, X 10 lbs. 33 lbs.
Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. X No Yes ENVIRONMENTAL CONDITIONS
Will work in warm/cold environments. No X Yes 30-100 F Range
Will work in outdoor elements such as precipitation and wind. No X Yes
Will work in small and/or enclosed spaces. No X Yes
Will work in heights greater than 4 feet. No X Yes