Objective

Site Engineering & Maintenance Operations

• Perform and oversee preventative and corrective maintenance on production and facility equipment.
• Provide subject matter expertise (SME) support and ownership for GMP-critical systems including utility systems, HVAC, BMS, EMS (e.g., Lighthouse), and facility controls.
• Respond to alarms and troubleshoot utilities and mechanical systems as needed, including off-hours support.
• Use CMMS (e.g., Maximo or Blue Mountain) to manage maintenance activities, work requests, documentation, and performance logs.
• Maintain master data for equipment and develop and implement maintenance plans and SOPs.
• Define and execute a site facilities and maintenance strategy aligned with company growth and regulatory needs.
• Directly manage and develop site-based facility and engineering staff, including Facility Engineers, and other support personnel.
• Lead day-to-day oversight and performance of GMP cleanrooms, ensuring they meet operational and regulatory standards.
• Coordinate janitorial service providers and cleaning contracts to maintain site compliance and presentation.
• Provide hands-on support to the vivarium to ensure compliance with facility-related animal care standards.
• Serve as a resource to other sites within the network for engineering and metrology-related guidance.

• Lead or support the design, planning, and execution of capital and facility improvement projects.
• Collaborate with cross-functional teams including Project Engineering (e.g., Billerica team) to deliver new systems and upgrades.
• Author and execute Change Controls, commissioning/validation protocols, and technical documentation in alignment with GMP requirements.
• Support investigations and root-cause analyses for equipment- or facility-related deviations or issues.
• Oversee and execute commissioning, IQ/OQ/PQ protocols, and qualification activities in compliance with regulatory requirements.
• Lead or support construction and facility build-out projects, including design reviews and vendor management.

• Coordinate office operations, room setups, and employee moves across the Iowa site.
• Act as the primary contact for external vendors and contractors.
• Ensure continuous operational readiness of office, lab, and manufacturing spaces.
• Lead contract negotiations and performance oversight for site janitorial and facility-related vendors.
• Work cross-functionally to support seamless operations of both lab and office environments.

• Promote and adhere to strong safety practices, including the appropriate use of PPE and identification of hazards.
• Work in varying environments, including confined spaces, radiological areas, and elevated heights or weather conditions.
• Ensure full compliance with applicable OSHA, FDA, NRC, and local regulations for site operations.
• Champion continuous improvement in EHS performance and compliance.

Qualifications

Education/Experience

• Associate degree or equivalent military experience.  A bachelor’s degree in an engineering discipline is strongly preferred; an advanced degree is a plus
• 10 or more years of relevant experience in maintenance and engineering, preferably within a pharmaceutical GMP environment.
• Hands-on experience with facility systems, utilities, automation controls, and troubleshooting required.
• Previous leadership experience managing cross-functional teams and third-party vendors.
• Experience working with radiopharmaceuticals is strongly preferred, but candidates with strong facilities or engineering leadership experience in related regulated industries (e.g., pharma, biotech, medical device, nuclear) will be considered.
• Experience with cleanroom operations, commissioning (IQ/OQ/PQ), and facility build-outs.
• Demonstrated ability to serve as a broader-based operational leader across a multi-functional site.
• Proven ability to balance tactical hands-on work with strategic oversight and planning.

Knowledge / Skill / Ability

• Strong leadership and team management skills, with the ability to develop, coach, and direct cross-functional technical teams.
• Excellent communications, interpersonal and collaboration skills, and ability to interact professionally with a wide range of individuals and organizations, internal and external.
• Experience with capital project planning, execution, and startup, including vendor management, budgeting, and cross-departmental coordination.
• In-depth knowledge of cGMP requirements and maintenance documentation practices.
• Strategic problem-solving abilities with the capacity to assess risk, evaluate options, and implement effective solutions under pressure.
• Demonstrated ability to manage competing priorities in a regulated manufacturing environment.
• Understanding of facilities-related compliance requirements (e.g., FDA, NRC, OSHA, ISO, and DEA).
• Familiarity with cleanroom management, IQ/OQ/PQ, and utilities qualification protocols.
• Ability to work independently with minimal direction, and drive deliverables through to completion by deadlines provided.
• Flexibility to support off-hours operations, construction activities, and urgent facility response situations.

Work Environment

• Must be willing to work in a facility producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
• Ability to use standard hand/power tools and perform basic electrical, carpentry, or mechanical tasks.
• Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including radioactive, corrosive, flammable and toxic material, dust, dirt, odors, and irritants.
• Physical ability to access mechanical areas and respond to emergencies when needed, including lifting up to 50 lbs., working in confined spaces, and meeting respirator fit test requirements.
• May be required to sit or stand for long periods of 8+ hours a day while performing duties. 
• Occasional kneeling, crouching, twisting the upper body, bending, stooping, pushing, pulling, or reaching may be required.
• Must possess good hand-eye coordination; close attention to detail is required.
• Must be willing to wear a variety of Personal Protective Equipment (PPE), including eye and hearing protection, as needed.
• Willingness to complete safety training within allotted timeframes, and work in a team-based environment.