Facility Engineer

We are a a global medical technology leader in neurosurgery and regenerative medicine driven by our purpose of restoring patients’ lives. We offer a broad portfolio of products and innovative solutions for dural access and repair, cerebral spinal fluid management and neuro-critical care.

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

The Sr. Facility Engineer II is responsible for initiation and implementation of a range of facilities critical utilities and equipment projects in the GMP manufacturing, laboratory, support, and non-GMP spaces of the Collagen Manufacturing Center (CMC). Projects range from construction, equipment specification and installation, qualification, rearrangements, specialty fabrications, and expansions, and may range upwards of $10M possibly spanning years. The Sr. Project Engineer is responsible for multidisciplinary projects from definition through project hand off, including specification, design oversight of cost estimating, scheduling, project management, construction administration, validation, with the goal of optimizing Asset Life Cycle Management and sustainability by using Good Engineering Practices in support of supply chain integrity. The Sr Facility Engineer ensures that the project planning and execution protects the identity, quality, durability, reliability, safety, and effectiveness of medical devices and, thereby, protects patient safety.

Sr. Facility Engineer II, Performance Excellence –

Takes a holistic approach to Asset Life Cycle Management of the GMP manufacturing facilities, utilities, and equipment. Projects within this role extend to mechanical spaces, offices, amenities, environmental controls, and safety. The goal is to ensure that the facilities remain within their validated states and in a constant state of continuous inspectional readiness.
Constantly monitors the performance of all facilities ensuring that performance, upkeep, and use to support the needs of GMP manufacturing, and attendant groups.
Manages medium to large-scale projects of varying degrees of complexity and financial magnitude.
Establishes budget and accurate spending projections, manage within capital and operating resources, and able to identify significant capital spend requirements during budget preparation.
Generates RFI/RFQ/RFP, SOW, specifications, sequence of operation, value engineering, project budgeting, and construction cost estimate, SOP.
Relevant experience working with regional architects, designers, MEP engineers, structural, and specialty professional engineers.
Plays a key role in Technology Transfer ensuring that manufacturing specifications are well within facilities’ validated states.
Plays a leadership role in equipment trouble shooting, repairs, and restorations.
Partners with relevant stakeholders to develop Validation Master Plans and validation protocols for new or restored GMP facilities/utilities/equipment. Plays a leadership role in protocol execution, receipt of data, data analysis, discrepancy resolution, final reports, final approvals, and assembly of handover packages
Responsible for attendant documentation, such as CAD drawings, city permits, safety permits, etc.
Submits necessary Change Controls carrying them through closure and final approval.
Coordinates work with the recipient departments.
Plays a key role regarding facilities work during shut down maintenance cycles.
Assist in authoring SOPs for the use and maintenance of the installed equipment.
Actively participates in cross-functional teams addressing Deviations, Non-Conformances, and CAPAs as required.
Ability to coordinate numerous projects simultaneously.
Strong negotiating skills
Knowledge of construction and facility management concepts, techniques and terminology.

DESIRED MINIMUM QUALIFICATIONS

Bachelor's degree in Mechanical Engineering or Facilities Engineering preferred. Relevant technical science, or military experience equivalent will be considered.

5+ years specifying and designing HVAC or critical utility systems (WFI, CCA, Clean Steam).
5+ years in the care of facilities used GMP manufacturing in the FDA-regulated industries preferred.
Knowledgeable in various off-the-shelf software applications (MS Office, MS Project) and customized systems (CMMS)
Strong problem-solving and analytical skills.
Ability to communicate effectively at all levels (both oral and written) both to in-house and external officials, where required.
Medical device critical Facilities experience is preferred.
Demonstrated ability to provide high-level customer service.