Facilities Engineer III (pharma)

Qualifications:

• Bachelor's Degree in Mechanical, Electrical or Chemical Engineering or equivalent combination of education & experience required
• Minimum of 8 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, waste water, 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

Job Description:

The 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.

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