Equipment & Facilities Manager

Based in Dartmouth, Precision BioLogic is a privately held medical device company that develops, manufactures, and markets a range of specialty diagnostic products used to assess blood coagulation disorders in clinical laboratories around the world. The company has developed a strong reputation in its niche and counts most of the major hospitals and reference laboratories in North America among its direct customers. On November 1, 2018, Precision BioLogic completed the acquisition of Affinity Biologicals Inc., a primary manufacturer of regents and kits used in hemostasis and thrombosis research and diagnostics located in Ancaster, Ontario.

**Role Description**

The Equipment & Facilities Manager is responsible for the purchasing, implementation, maintenance, care, and efficient operation of all equipment (except that managed by IT) and facilities used by the organization. This position reports to the Director of Operations and will monitor and support systems and services that include heating, lighting, refrigeration, air conditioning, plumbing, pest control, water purification, lab equipment and analyzers, air filtering, and electrical systems as required by Precision BioLogic’s quality system.

The Equipment & Facilities Manager is a cross-functional, intra-company role (approx.travel 20% to Ancaster, ON) with the mandate to support organizational effectiveness through the execution of the business strategy and by focusing on the following four areas:

- **Continuous Improvement** - document workflow processes, design methods to determine improvement opportunities, propose, test, and implement improvements to support operational improvements.
- **Facilities Management** - ensure sustainable GMP compliant environmental conditions for both the manufacturing process and employee safety and comfort.
- **Process Equipment** - evaluating processes and equipment to ensure compliance with environmental and safety regulations.
- **Process Qualification and Validation** - with the input of the manufacturing team, ensure operating reliability and compliance of process equipment and maintain continuous validation of core manufacturing processes

Your responsibilities will include:
**Continuous Improvement**
- Collaborate with the management team members and assigned functional process owners across all areas of the business for which procedural or system changes will improve overall operational effectiveness.
- Support the continuous improvement of sound business practices and coordinate technology solutions; develop and use work aids, such as process descriptions, checklists, templates, flowcharts, and guides to assist personnel with implementing defined processes; provide training to employees to improve their process improvement skills.
- Support organizational issues and concerns, and assist in the development of organized change strategies and plans and/or conduct training for project implementation; review and write comprehensive technical records and reports, identify alternatives, and make recommendations; oversee work simplification studies, and evaluate operations and procedures
- Under the oversight of the PMO, and working with responsible teams, lead process improvement projects and assist in the rollout between departments/companies and coordination of resources.
- Be a champion for change.

**Facility Management**
- Monitoring of facility alarms through associated software.
- Oversight responsibility for facility operating and maintenance budget.
- Collaborate with Supply Chain Manager and functional owners on contract negotiations.
- Ensure continuous GMP compliance of environmental conditions.
- Oversee the implementation and maintenance of a facility-wide work order tracking system for facility maintenance and repairs.
- Work with external contractors (e.g., electricians, plumbers, alarm monitoring, pest control, etc.).

**Process Equipment**
- Monitoring of equipment alarms through associated software.
- Support assigned Process Equipment Owners (Operations, R&D and Quality) in the development and performance of Site Acceptance Testing (SAT) and Factor Acceptance Testing (FAT), commissioning and other acceptance activities.
- Support Process Equipment Owners (Operations, R&D and Quality) in the review and/or approval of User Requirement Specifications (URS), Functional Requirement Specifications (FRS) and other layout or process design activities.
- Write/execute/review the equipment qualification document (IQ, OQ, PQ) in strict adherence to the approved qualification protocols to ensure a successful installation.
- Provide support to the New Product Development Team with the design and validation of new workflow processes and selection of new process equipment.
- Support Quality Assurance with the input of new equipment information into the Equipment Database and ensure the required maintenance and calibration activities are correctly defined to comply with manufacturers and regulatory requireme