Sr. Mgr, Engineering Manager

Supervision Exercised

Under direct supervision of the Plant Manager this position will directly manage facilities and maintenance managers, supervisors, engineers, and technicians.

Key Responsibilities

Engineering and Facilities Management

• 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.

Environmental, Health and Safety Responsibilities

• Ensure his team’s completion of all required safety training and their compliance with site safety policies and procedures.
• Partner with EHS manager to manage facility emergency response programs, evacuation plans, and business continuity preparedness activities.
• Ensure contractor compliance with site safety requirements.
• Member of site EHS committee.

Quality and Compliance Responsibilities

• Ensure compliance with applicable FDA regulations, Quality System Regulations, ISO standards, OSHA requirements, environmental regulations, and company policies and procedures.
• Partner with Quality Assurance to maintain the effectiveness of the Quality Management System and support inspection readiness activities.
• Support internal audits, customer audits, and regulatory inspections.
• Ensure engineering and facilities documentation is maintained in accordance with Good Documentation Practices and quality system requirements.
• Participate in management reviews, risk assessments, and continuous improvement activities.

Training and Development

• Ensure personnel are properly trained and qualified to perform assigned responsibilities.
• Coordinate EHS orientation training and ongoing safety training programs.
• Support development of training curricula for engineering, facilities, maintenance, and EHS-related activities.
• Promote employee engagement, professional development, and technical competency growth.
• Perform other duties as assigned.

Skills & Competencies

• Bachelor's degree with a minimum of 8 years of relevant engineering, facilities, maintenance, or EHS experience.
• Minimum of 3 years of leadership experience in a regulated manufacturing environment.
• Experience in medical device, biologics, tissue technologies, pharmaceuticals, or other FDA-regulated industries preferred.

Preferred Qualifications

• Master's degree in Engineering, Environmental Health & Safety, Facilities Management, or Business Administration.
• Professional Engineering (PE), Certified Safety Professional (CSP), Certified Industrial Hygienist (CIH), or similar certification.
• Lean Six Sigma Green Belt or Black Belt certification.
• Experience supporting FDA inspections and ISO audits.

Tools And Equipment Used

This role requires regular use of tools and equipment relevant to the work environment. Examples include: General office equipment: Computers, printers, copiers, fax machines, and telephone communication systems. Software and systems: ERP systems (e.g., SAP), CRM platforms, statistical analysis tools, project management software (e.g., MS Project, Jira), QMS platforms.

Physical Requirements

The physical requirements listed below represent the motor and physical abilities necessary to successfully perform the essential duties of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to enable individuals with disabilities to perform these duties. While performing the responsibilities of this role, the employee is expected to: Sit, listen, speak, and move throughout various areas of the building. Travel across all company locations as needed. Periodically lift and/or move items up to twenty-five pounds. Travel domestically and internationally via car, train, or airplane, as required by the role.