Job Description

SME with a deep technical expertise in all systems under his/her responsibility (GMP HVAC, GMP Utilities and ancillary systems associated within their facilities), understanding their applications in pharmaceutical manufacturing, well versed with flow charts and process parameters, and awareness of industry trends.

· Ensure the assigned processes are in alignment with the applicable regulatory Industry and Client's Standards.

· Support risk assessment exercises using the different tools available (eg.FMEA) and participate as required in teams, committees, or other groups and/or individually to achieve the departmental, site and/or company goals.

· Lead or participate in projects/changes for all the systems under his/her responsibility including design, verification activities (IV/OV/PQ), as user representative for capital projects or delivery agent for local projects.

· Develop the proper documentation (URs, Specification, test cases, etc..) to demonstrate that systems are properly installed, qualified and started up and that remains in a controlled state.

· Monitor utility systems and maintain KPI's to assure that they are operating properly, in compliance with requirements.

· Provide written instructions for the proper way to operate and maintain the equipment and process to assure that the system operates within the controlled parameters.

· Implement efficient and effective maintenance and reliability techniques.

· Apply problem solving skills by leading equipment failures, troubleshooting, demonstrating RCA lead investigator proficiency and guide operations personnel in the resolution of process issues.

· Provide customer consultation and notifications on issues that involve utilities areas. Assure that all necessary items are identified on the proper tracking systems, and make sure that items are completed by the required date.

· Provide technical assistance as necessary to maintenance, and operations personnel.

· Support internal and external inspections and investigations (including Quality and HSE).

· Maintain efficient communications with appropriate site customer groups.

· Proficiency with the DMS and CAPA systems.

· Maintain, develop, and conduct operations training of utility systems.

· Utilize statistical analysis tools to determine the process control, and capability for investigations.

· Participate in Process Hazard Review meetings and/or Safety Teams as required by leadership

Education/Experience

· Bachelor’s degree in engineering or relevant sciences and 4 years of experience with GMP Utilities

Experience with Air Compressors, chilled water, steam boilers, Air Handling Units, heating hot water, waste water) and clean utilities ( Clean compressed air, Water for Injection, Nitrogen, Clean Steam ).

· Start-up experience preferred.

· Advanced degrees or certification relevant to the role is a plus.

· Ability to think strategically and tactically (detail-oriented).

· Strong collaborative and influencing skills, and ability to work well in a cross-functional, matrixed environment.

· Demonstrated ability to work in a fast-paced team environment, meet deadlines, and prioritize work.

· Proven track record of being self-motivated and capable of working with cross-functional teams while remaining positive towards project challenges.

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