Facility Operations Manager

Prerequisites

• Experience within the pharmaceutical/biotechnology industry or CDMO industry is desirable, but not required.
• > 7 years of facility support experience.

Responsibilities

• Perform repair and maintenance to the J-Star Research facility and systems in accordance with J-Star Research’s high safety and appearance standards, and ensures optimum efficiency and reliability of electrical, mechanical, automation, utility, data and information technology systems.
• Responsible for the routine maintenance and upkeep of the entire facility with respect to the following areas: Heating and air conditioning (HVAC), Water and Plumbing, Lighting, Electrical (including the back-up generator and USBs), Security and Alarms, Card Key Access Control, General upkeep and repairs, General Safety, and Information Technology (Computers, Networks, etc.).
• Devise, implement and oversee infrastructure installations, modifications and expansions of laboratory, production and general facility areas as well as equipment and instruments.
• Research production/processing equipment or fixtures for purchase and gathers data relating to their ability to meet organizational needs. Ensure that established efficiency and safety targets are met. Modify production/processing equipment or fixtures as need in alignment with internal stakeholder needs.
• Maintains operations and ensures work is performed in compliance with all state and federal guidance and regulations, including but not limited to GMP, DEA, EPA, FDA, OSHA etc.
• Responsible for contributing to audit readiness and for participating in audits with customers, the FDA and other Regulatory Agencies, as needed.
• Work with internal stakeholders and third party resources to develop and maintain preventative maintenance procedures and schedules for the maintenance for the facilities and related equipment in alignment with the facility lease agreement and J-Star requirements.
• Monitor, track and coordinate all corrective and preventative maintenance work activity and inspects/reviews outside contractor work and provides internal approval for payment.
• Minimize reliance on outside third party vendors and perform basic maintenance and repairs on electrical, mechanical, automation and utility systems.
• Assess the needs of the facility with respect to maintenance and upkeep of the physical facility and communicate with Management, Production and the Quality Unit with observations and recommendations on a periodic basis.
• Liaison with the Landlord on facility-related issues.
• Work with outside contractors, Landlord, and township for building and process related construction projects.
• Provide necessary coordination for the completion of contracted work as assigned.
• Superuser for the building automation system with the ability to make program and set point changes, add new devices to the system and program such changes.
• Maintain an uncompromising focus on quality, documentation, confidentiality and technical execution.
• Read and understand blue prints and schematics.
• Create and edit CAD drawings.
• Create, monitor and track purchase orders.
• Contribute to writing and editing SOPs.
• Follow all company, site and laboratory Environmental, Health and Safety (EHS)-related protocols, processes, guidelines and SOPs.   Actively participate in EHS discussions with J-Star Research stakeholders and management for continuous improvement of EHS practices.
• Insure that all EHS systems (eye wash stations, safety showers, sprinkler systems, fire alarms, etc) are fully operational.
• Participate in the on-call process for responding to emergency calls on nights, weekends and holidays.
• Provide Card key access oversight and programming.

Qualifications

• Proven track record of setting and meeting aggressive targets as related to safe, timely execution of objectives.
• Excellent written, verbal and communication skills.
• Ability to prioritize and manage numerous projects simultaneously.
• Ability to interact in an effective and appropriate manner with diverse population sets.
• Ability to communicate candidly, clearly and timely.
• Experience in working on, positively contributing to, and leading teams.
• Proficient in Microsoft®Office™, AutoCAD® and other job-related software and applications.
• Ability to perform the physical requirements of the position. Must be able to walk, stand, crawl, stoop, crouch, bend or reach above and below shoulders height frequently. This job requires frequent twisting and turning of the body and the use of both hands.

Reporting Relationship

• Reports to the Facility Site Head