Engineering & Facilities Leader, GMP & Compliance

Integra LifeSciences; Braintree (MA); On-site; USD 125,000 - 173,000; Full time

Job summary

Integra LifeSciences in the United States is seeking a Senior Manager, Engineering Manager to lead engineering, facilities, maintenance, and EHS programs for manufacturing operations. You will drive compliance, asset management, and capital projects while partnering with Quality, Operations, and Supply Chain.

The role requires 8+ years in engineering/facilities with leadership experience in regulated environments; FDA/ISO knowledge is preferred.

Qualifications

• Bachelor’s degree in engineering with 8+ years in facilities/engineering leadership.
• 3+ years of leadership in a regulated manufacturing environment.
• Experience with FDA-regulated industries preferred.
• Knowledge of EHS and quality systems.

Responsibilities

• Lead engineering, facilities, maintenance, and utility operations to support manufacturing and business objectives.
• Ensure facilities, equipment, utilities, and infrastructure are maintained in compliance with applicable regulatory, safety, and quality requirements.
• Develop and implement preventive maintenance, calibration, reliability, and asset management programs.
• Manage engineering projects, facility modifications, equipment installations, utility upgrades, and capital improvement initiatives.
• Provide technical leadership for equipment qualification, facility validation, process improvements, and continuous improvement activities.
• Support manufacturing operations by identifying and resolving equipment, facilities, and process-related issues.
• Develop departmental budgets, capital expenditure plans, and resource forecasts.
• Manage contractors, vendors, and service providers to ensure work is completed safely, efficiently, and in compliance with company requirements.
• Coordinate facility inspections, repairs, maintenance activities, and utility monitoring programs.
• Ensure adequate capacity planning and infrastructure support for current and future business needs.
• Maintain facility drawings, engineering documentation, equipment records, and maintenance history files.

Skills

Engineering leadership

Facilities management

Regulatory compliance

Budgeting

Vendor management

Education

Bachelor’s degree in engineering

Master’s degree in Engineering/EHS/Facilities

Professional Engineering (PE)

Certified Safety Professional (CSP)

Certified Industrial Hygienist (CIH)

Tools

SAP

MS Project

Jira

Job description

Integra LifeSciences in the United States is seeking a Senior Manager, Engineering Manager to lead engineering, facilities, maintenance, and EHS programs for manufacturing operations. You will drive compliance, asset management, and capital projects while partnering with Quality, Operations, and Supply Chain.

The role requires 8+ years in engineering/facilities with leadership experience in regulated environments; FDA/ISO knowledge is preferred.