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The Sr. Project Engineer 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, cost estimating, scheduling, project management, construction administration, and validation/commissioning, with the goal of optimizing Asset Life Cycle Management and sustainability by using Good Engineering Practices in support of supply chain integrity. The Sr Project 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.

Job Responsibilities

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The incumbent will be responsible for managing site-based facility projects in a highly regulated cGMP environment, coordinate project scope definitions, manage project timelines and budgets, develop schedules and collaborate with stakeholders, etc.

• The incumbent will be responsible for working with vendors and consulting engineers to ensure project execution meets quality standards.

• Provides multi-disciplinary technical input to project design personnel to ensure compliance with site requirements/project specifications/codes and permitting requirements.

• Serves as the Facilities Core Team Leader for all site-based process transfers and product commercialization projects.

• Lead implementation of projects involving critical building systems including, but not limited to HVAC, ISO Classified Clean Rooms, WFI, Clean Steam, Clean Compressed Air and Gases, Chilled Water etc.

• Define method and plans for project execution consistent with the business need and justification.

• Identify key project risk areas and potential resolution plan and related impact.

• Coordinate definition, preparation and delivery of project deliverables, design documents, and bid packages.

• Evaluates and approves engineering and project design changes, specifications, and drawing releases.

• Provide status and progress reports to management and project team.

• Coordinate plant training needs to ensure a smooth transition and project closing

• Conduct surveys and prepare schematic, preliminary and work drawings for the construction and maintenance of new or remodeled facilities.

• Consult with architects, engineers, owners, and contractors regarding preliminary layout, construction procedures, and code requirements that apply to building projects.

• Inspect existing facilities and utilities to determine their condition and prepares reports to document the condition, deficiencies observed, designs necessary for repairs, and estimated cost of repairs.

• Manages cost, schedule, and scope of facilities related projects including renovations, new equipment installs, and new construction.

• Oversees facility projects to ensure contractor compliance with safety, site cleanliness, and all current good manufacturing practices (cGMP's).

• Coordinates projects with other departments to minimize risk and impact to existing and ongoing operations.

• Provide leadership and direction to staff involved in the designs of site facilities, and schedules

• Ability to maintain documents, records, and prepare reports and correspondence related to the work. Manage and execute appropriate change control for the revision of existing equipment and systems maintenance SOPs.

• Responsible for maintenance and facility related Quality System Events, Non-Conformances and CAPAs

• Manage and execute appropriate change controls for the revision of existing equipment and systems, maintenance SOPs and drawings.

• Participate in cGMP audits as the maintenance, facility and utility systems Subject Matter Expert

• Establish and maintain contacts with vendors and equipment manufacturers; develop and review specifications and costs; orders new equipment and parts.

• Identify and manage inventory of critical equipment spares.

• Development of site policy and procedures, and communication to subordinates to ensure compliance.

• Supports facility equipment validations and decommissioning projects.

• Develop and maintain facility operational and maintenance procedures.

• Develops and maintains a positive relationship with functional managers, lead personnel, and operators.

• Interacts with contractors and vendors to receive and negotiate bids and monitor the progress and completion of projects.

Qualifications:

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

• BS in Engineering (Mechanical Engineering preferred) with minimum of 5+ years of experience in the design and construction of GMP and non-GMP production facilities in a manufacturing plant environment, preferably in the Medical device or Pharmaceutical industries.

• Knowledge of ISO 5/7/8 Clean Room Construction, Operation, and Certification Process

• Knowledge of cGMPs, FDA and ISO Guidelines and Regulations for Medical Device or Pharmaceuticals Knowledge of troubleshooting mechanical, HVAC, clean utilities, electrical, pneumatic and refrigeration systems

• Proficient in Root Cause Analysis (RCA) and Failure Mode and Effects Analysis (FMEA).

• Strong writing and communication skills.

• Knowledge on personal computer and software like MS Word, Excel, Project and Power Point

• Experience with CMMS and CMS systems

• Able to work with minimal supervision

• Must be available in emergency situations, and / or work flexible hours.

TOOLS AND EQUIPMENT USED

Oracle R-11 and R-12, MS Office, MS Projects, and CAD, measurement tools, handheld and fixed diagnostic tools.

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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