The PositionThe purpose of this position is to lead maintenance and optimization of 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, leadership and mentoring of junior team members. All activities are aligned with Environmental Health & Safety (EHS) program requirements.
RelationshipsReports to Manager, Facilities Maintenance and Engineering.
Essential Functions- Create & maintain system specifications for black utilities
- Support all design, installation, commissioning, qualification, training activities for black utilities, as system owner/expert
- Provide additional technical support to project team as required
- Adhere to all Quality & environmental regulations within area of responsibility
- Support technical development of Facilities Technicians after handover to LOB
- Continuous process improvement using cLEAN® concepts
- Maintain & establish standards for procedures & maintenance plans
- All safety & environmental requirements in the performance of duties
Physical RequirementsMoves 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
- 8-15+ 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
- Thorough knowledge of black utilities systems to include: chilled water, plant steam, compressed air, vacuum, wastewater, cryogenic storage, HVAC. Demonstrated ownership and innovation of black utility systems required
- Knowledgeable in clean utilities systems to include: WFI, pure water, clean steam, process air, electrical required
- Ability to read/review design drawings (CAD) with a basic understanding of P&ID, HVAC, & Electrical systems required
- Thorough understanding of technical documents such as URS, SAT, FAT, Validation Protocols preferred
- Thorough understanding of complicated product documentation & standard operating procedures with attention to high-level concepts required
- Computer literacy with associated systems preferred
- Demonstrated knowledge and proficiency in change control processes and familiarity with validation and commissioning methodology and processes required
- 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
