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The Project Engineering Manager is responsible for the technical and administrative leadership of facilities, utilities, equipment, and automation projects in the GMP manufacturing, laboratory, support, and non-GMP spaces of the Collagen Manufacturing Center (CMC). Projects range from construction, equipment installation, rearrangements, specialty fabrications, and expansions, and may range upwards of $10M possibly spanning years. The Project Engineering Manager is responsible for multidisciplinary project definition through project hand off, including 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 Project Engineering Manager ensures that the project planning and execution protects the identity, quality, durability, reliability, safety, and effectiveness of medical devices and, thereby, protects patient safety.

Direct supervision is exercised over the Lyophilizer, Utilities, HVAC, Project Engineers, Automation Engineers, Senior CAD Operator, and contractors and technicians involved with project implementation.

Indirect supervision is partnered with multidisciplinary teams to ensure that projects meet their intended goals and are executed with quality, coordination, and compliance.

ESSENTIAL DUTIES AND RESPONSIBILITIES

To succeed in this role, the Project Engineering Manager is responsible for:

• Safety - Ensures that all team members receive training from Integra LifeSciences’ Safety department, and are knowledgeable and compliant regarding safety procedures, policies, permits, practices, PPE, and awareness. Initiates and leads accident, near miss reviews and incident notifications. Ensures proper housekeeping procedures are maintained.

• Quality - Responsible for the team’s compliance and meeting the quality standards as defined by Integra’s SOPs, GMPs, Global Quality Standards, local and procedures, where applicable.

• Manage People Effectively - Responsible for managing staffing, training and daily maintenance operations across shifts up to 7 days a week, including attendance, overtime, operational issues, talent management, performance management, development planning and reporting of results. Also interviews job candidates, completes performance reviews, and justifies promotions or disciplinary actions (as appropriate).

• Project Engineering Manager Excellence – Translate the needs of multidisciplinary stakeholders into project engineering plans with the specific goal of initiating and optimizing Asset Life Cycles. This may involve external resources such as engineering firms, financing sources, environmental representatives, and local permitting authorities.

• Partner with recipient departments assisting in equipment selections and facilities designs. Assists with authoring User Requirements Specifications.

• Develop plans, drawings, timelines, and budgets with cash flow requirements to gain multidisciplinary agreement.

• Partner with relevant stakeholders to develop Validation master plans, and validation protocols including those which must be executed simultaneously within the project progress.

• Team with recipient stakeholders to prepare justifications with proposed supply chain enhancements and CapEx submissions.

• Submit necessary Change Controls.

• Issue Purchase orders, obtain permits (where necessary).

• Perform kick off meetings including contractors and stakeholders.

• Hold daily meetings with contractors to hold them to schedules of key deliverables, review change orders, mitigate risks, and to assess actual on-site progress. Keep extensive notes.

• At least weekly, communicates to all stakeholders the project progress against actual-to-planned timelines and budgets. Include coordination, logistics, change orders, issues of negative impact, and track decisions. Issue minutes to all stakeholders.

• Perform start-up and/or commissioning of all facilities and equipment, and execute relevant validation protocols.

• Assist in authoring SOPs for the use, cleaning, and maintenance of the installed equipment.

• Prepare handover package inclusive of plans, As-Built drawings, approvals, minutes, and OEM documentation.

• Consult with the Validation groups to assist in protocols, address discrepancies, update SOPs, and close projects.

• Close out all permits.

• Actively participates in cross-functional teams addressing Deviations, Non-Conformances, and CAPAs on current and completed projects.

DESIRED MINIMUM QUALIFICATIONS

• Bachelor's degree in Engineering or relevant technical science, or military experience equivalent.

• PMP certification is preferred.

• A Professional Engineer license is desirable.

• 5+ years of project management and automation in the FDA regulated industries.

• Knowledgeable in various off-the-shelf software applications (MS Office, MS Project, CAD) and customized systems (CMMS)

• Knowledgeable in setting and following budgets.

• Demonstrated abilities to enhance staff talent and careers through mentorship and training.

• 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.

• Solid regulatory compliance knowledge (GMP, OSHA, etc.)

• Medical device project engineering is preferred.

• Demonstrated ability to provide high-level customer service.

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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