Ready to make a difference by utilizing your talents? Join a team driven by a mission to help patients, and a culture focused on developing medical device and diagnostic solutions.
Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities. The Company mission remains to improve the detection and treatment of disease.
The Facilities Manager provides mechanical and electrical oversight of systems used in manufacturing, research, development and commercial operations. Provides support and guidance to engineers, scientists and facilities technicians to ensure that facility and equipment capacity is available, and that facility and equipment performance does not constrain utilization. Proactively leads facilities and equipment enhancement projects as required by internal customer groups.
Clean Room Environment Controls (20%)
- Maintain and continually assess the effectiveness of clean room environmental controls
- Assist and coordinate with clean room system owners on environmental out-of-tolerance investigations and implementation of appropriate corrective and preventive actions
- Conduct clean room monitoring and performance trending
Clean Utilities Systems (10%)
- Oversee routine maintenance of critical systems such as DI water systems, compressed air, fume hoods, HEPA filters, dry room, cold rooms and any other critical system maintenance
- Lead investigations into out-of-tolerance conditions on these systems and implement appropriate corrective and preventive actions
Manufacturing Equipment Controls (20%)
- Ensure that facilities and manufacturing equipment complies with life cycle expectations, from requirements development through asset induction, use and retirement
- Provide front line support for troubleshooting and resolving functional and performance problems with manufacturing equipment
- Ensure non-routine maintenance of manufacturing equipment is investigated, completed and documented
- Work with system owners to define and schedule routine preventive maintenance of manufacturing equipment
- Ensure that new and revised equipment is appropriately qualified by writing and executing IQ, OQ and PQ protocols
- Coordinate outside services as needed for construction, maintenance, and repair
- Assist with construction and renovation related to facility expansion, design and modification. Assure all systems are operational after build-outs are completed and perform room qualifications
- Serve as “employee on call” 24/7 in event of a facility and/or equipment emergency, requires evening and weekend work
- Lead and/or provide guidance for the planning and execution of facilities and equipment projects
- Provide support for facilities technician
- Manage activities leading to the successful execution of assigned projects. Control project scope, schedule and budget relative to the established baseline
- Communicate and collaborate across functional and leadership teams to inform project status and risks, elevate issues, present recommendations, and implement modifications or project plans
- Creates and maintains productive environment to enable the delivery of various facility services. Empowers and oversees team to carry out operational responsibilities and works directly with team to carry out objective
- Works with EHS to ensure compliance to OSHA regulations and maintain a safe work environment at the sites
- Ensure compliance
- Follow-up on action items between meetings and ensure team member accountability
- BA/BS Degree in Engineering or Technology, or commensurate years of experience
- Experience in Project Management experience in GMP industries (Pharma/Biotech/Medical Device)
- 5+ years of experience providing work direction and leadership
- Great communication and team building skills - ability to lead cross functional teams
- Ability to prioritize competing demands
- Availability after normal working hours
- Ability to read and understand blueprints
- Knowledgeable in mechanical, electrical, and plumbing systems
- Knowledgeable in Building Automation Systems
- Working knowledge of security, maintenance operations, administrative services, contract management, janitorial and grounds maintenance
Surmodics offers a competitive compensation and benefits package, including a bonus program, 401(k) with employer match, employee stock purchase plan and stock options.
Surmodics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.