Facilities Engineer I - Clean Utilities - PS AM 2

About the role

The purpose of this position is to maintain and optimize all clean utilities systems for the DFP-US facility. Responsibilities include but are not limited to: writing/reviewing specifications; design reviews; equipment installation; commissioning & qualifications; SOP development; maintenance development & training; management of cost, quality & schedule within area of responsibility; establishing & maintaining positive working relationships with internal & external engineering team & stakeholders. All activities are aligned with Environmental Health & Safety (EHS) program requirements.

Responsibilities

• Maintain and improve system specifications for clean utilities
• Support all design, installation, commissioning, qualification, training activities for clean utilities, as system expert/owner
• 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

Requirements

• 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
• Knowledge & experience in the operations, maintenance, & design of cGMP utilities as well as working in a regulated environment (FDA, cGMP, OSHA) preferred
• Knowledgeable in clean utilities systems to include: WFI, pure water, clean steam, process air, electrical. Prior ownership/work experience preferred
• Knowledgeable in black utilities systems to include: chilled water, plant steam, compressed air, vacuum, waste water, cryogenic storage a plus
• Understanding 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

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
• Knowledge & experience in the operations, maintenance, & design of cGMP utilities as well as working in a regulated environment (FDA, cGMP, OSHA) preferred
• Knowledgeable in clean utilities systems to include: WFI, pure water, clean steam, process air, electrical. Prior ownership/work experience preferred
• Knowledgeable in black utilities systems to include: chilled water, plant steam, compressed air, vacuum, waste water, cryogenic storage a plus
• Understanding 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