The Position

The purpose of this position is to contribute to the establishment of all utilities systems for the OFP Site Durham. Responsibilities include, but are not limited to, writing/reviewing specifications; design reviews; equipment installation; commissioning & qualifications & validation protocols; SOP development; maintenance development & training & management of cost, quality & schedule within area of responsibility. Establish & maintain positive working relationship with internal & external engineering team & stakeholders. Accountable for ensuring all activities are aligned with Environmental Health & Safety (EHS) program requirements.

Relationships

Reports to Senior Manager - OFP.

Essential Functions

• Create & maintain system specifications for black & clean utilities
• Support all design, installation, commissioning, qualification, training activities for black & clean utilities
• 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
• Coach & mentor junior-level engineers & engineering technicians
• All safety & environmental requirements in the performance of duties
• Other accountabilities, as assigned

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 related field of study from an accredited university required
• Minimum of two (2) years of engineering experience with clean & black utilities or similar equipment required
• In lieu of above minimum requirement can consider a minimum of five (5) years of engineering experience in a manufacturing facility required
• Knowledge & experience in the operations, maintenance & design of cGMP utilities as well as working in a regulated environment (FDA, cGMP, OSHA) required
• Knowledgeable in black utilities system to include chilled water, plant steam, compressed air, vacuum & wastewater management required
• Knowledgeable in clean utilities system to include process water, clean steam, process air, vacuum & cryogenic storage required
• Ability to read/review design drawings (CAD) with a basic understanding of P&ID, HVAC & Electrical systems required
• 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 required
• Computer literacy with associated systems required
• Ability to plan, coordinate & prioritize activities to ensure optimal use of resources in the department preferred