The Position

The purpose of this position is to contribute to the establishment of all black utilities systems for the DAPI-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

Reports to Manager, Facilities Engineering - Black Utilities API.

Essential Functions

• Create & maintain system specifications for black utilities
• Support all design, installation, commissioning, qualification, training activities for black 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
• 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
• 2-5+ years engineering experience in a manufacturing facility preferred
• 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 system to include: chilled water, plant steam, compressed air, vacuum, waste water management preferred
• Knowledgeable in clean utilities system to include: process water, clean steam, process air, vacuum, cryogenic storage a plus
• 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 preferred
• Revising the work plan for complex problems being resolved by cross functional teams preferred