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
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