The purpose of this position is to maintain and optimize all black utilities systems for the DFP-US facility. Responsibilities include but are not limited to: writing/reviewing specification; design reviews; equipment installation; commissioning & qualifications; SOP development; maintenance development & training; management of cost, quality & schedule within area of responsibility; establishing & maintaining positive working relationship with internal & external engineering team & stakeholders. All activities are aligned with Environmental Health & Safety (EHS) program requirements.
Relationships
Manager, Facilities Maintenance and Engineering.
Essential Functions
Maintain and improve system specifications for black utilities
Support all design, installation, commissioning, qualification, training activities for black utilities, as system owner/expert
Provide additional technical support for site project execution as required
Adhere to all Quality & environmental regulations within area of responsibility
Support technical development of Facilities Technicians
Continuous process improvement using cLEAN® concepts
Maintain & establish standards for procedures & maintenance plans
All safety & environmental requirements in the performance of duties
Physical Requirements
Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Routinely operates & inspects manufacturing equipment using hands. Ability to be on feet for up to a 12-hour shift. May require corrected vision to 20/25 based on role. May require color vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials. May be required to wear latex gloves. Occasionally performs critical job functions in extremely cold work environments. Occasionally positions oneself within confined spaces for inspection, repair & maintenance of equipment. Ability to work in loud noise environments with hearing protection. Occasionally works in outdoor weather conditions. Able to pass a driving exam for powered industrial trucks. Does not require a valid drivers license.
Qualifications
Bachelor's degree in Mechanical, Electrical or Chemical Engineering or equivalent combination of education & experience required
5-8+ years engineering experience in a manufacturing facility. Knowledge & experience in the operations, maintenance, & design of cGMP utilities as well as working in a regulated environment (FDA, cGMP, OSHA) preferred
Knowledgeable in black utilities systems to include: chilled water, plant steam, compressed air, vacuum, waste water, cryogenic storage, HVAC. Prior ownership/work experience required
Knowledgeable in clean utilities systems to include: WFI, pure water, clean steam, process air, electrical preferred
Ability to read/review design drawings (CAD) with a basic understanding of P&ID, HVAC, & Electrical systems preferred
Understanding of technical documents such as URS, SAT, FAT, Validation Protocols preferred
Understanding of complicated product documentation & standard operating procedures with attention to high-level concepts preferred
Computer literacy with associated systems preferred
Proven expertise in planning/organization/execution of project & maintenance activities, following up on results, & revising the work plan for complex problems being resolved by cross functional teams preferred