Senior Project Engineer

7 hours ago

Plainsboro, New Jersey, United States Integra LifeSciences Full time
About the Role

We are seeking a highly skilled and experienced Senior Project Engineer to join our team at Integra LifeSciences. As a key member of our facilities team, you will be responsible for the initiation and implementation of various projects related to facilities critical utilities and equipment in our GMP manufacturing, laboratory, support, and non-GMP spaces.

Key Responsibilities
  • Initiate and implement projects related to facilities critical utilities and equipment
  • Manage multidisciplinary projects from definition through project handoff, including specification, design oversight, cost estimating, scheduling, project management, construction administration, and validation/commissioning
  • Ensure that project planning and execution protects the identity, quality, durability, reliability, safety, and effectiveness of medical devices and, thereby, protects patient safety
  • Lead near miss reviews and incident notifications, and ensure proper housekeeping procedures are maintained
  • Manage people effectively, playing a key role in multidisciplinary teams
  • Take a holistic approach to Asset Life Cycle Management of the GMP manufacturing facilities, utilities, and equipment
  • Monitor the performance of all facilities, ensuring that performance, upkeep, and use support the needs of GMP manufacturing and attendant groups
  • Manage medium to large-scale projects of varying degrees of complexity and financial magnitude
  • Establish budget and accurate spending projections, manage within capital and operating resources, and identify significant capital spend requirements during budget preparation
  • Generate RFI/RFQ/RFP, SOW, specifications, sequence of operation, value engineering, project budgeting, and construction cost estimate, SOP
  • Partner with relevant stakeholders to develop Validation Master Plans and validation protocols for new or restored GMP facilities/utilities/equipment
  • Responsible for attendant documentation, such as CAD drawings, city permits, safety permits, etc.
  • Submit necessary Change Controls carrying them through closure and final approval
  • Coordinate work with recipient departments
  • Play a key role regarding facilities work during shut down maintenance cycles
  • Assist in authoring SOPs for the use and maintenance of installed equipment
  • Actively participate in cross-functional teams addressing Deviations, Non-Conformances, and CAPAs as required
Requirements
  • Bachelor's degree in Mechanical Engineering or Facilities Engineering preferred
  • 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, CAD) 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
About Integra LifeSciences

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

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