Facilities Engineer I/II - Wastewater Systems API

About the role

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 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

• 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

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 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
• 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

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
• 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