Position Summary:
The Senior Director of Facilities will be responsible for leading the Facilities Engineering department in accordance with current Good Manufacturing Practices (GMP), ISO requirements, and local, state and federal quality and environmental and safety regulations. The position will be accountable for developing and maintaining facilities and infrastructure strategies that shall meet Ocular's short and long-term manufacturing and R&D requirements (including the design through construction) of a future commercial manufacturing site. Strong cross functional collaboration is essential. This individual, in conjunction with the Manufacturing and Quality organizations, shall establish a continuous improvement culture in pursuit of industry recognized best practices that achieve regulatory requirements with regard to preventative maintenance, calibration management programs, and for manufacturing environmental control to ISO classification standards. This position is accountable to oversee and manage the Facility organization in ensuring the delivery of optimal operating performance/results for mechanical, electrical, plumbing, and HVAC systems while achieving compliance with local, state and federal regulations for both quality and safety/environmental
Duties and Responsibilities:- Oversee Facilities Engineering personnel and activities.
- Coordinate with cross functional Leadership and the SVP CMC Technical Operations on the development and implementation of Ocular's infrastructure strategies.
- Provide leadership and direction to the Maintenance, Calibration and Engineering staff.
- Ensure effective programs are in place to deliver appropriate maintenance and calibration of process equipment, utilities and infrastructure and that all facilities are consistently clean and orderly
- Ensure appropriate programs and oversight are in place for adequate parts inventory to allow for uninterrupted manufacturing and site activities.
- Collaborate with the Director of EHS and provide support in developing, implementing and managing EH&S policies, programs and practices to ensure a strong safety culture and compliance with local, state and federal requirements, including appropriate notification and filing of reports with the appropriate regulatory agencies as required.
- Responsible for identification, negotiation and appropriate oversight of outside contractors performing repairs, maintenance, calibration activities, janitorial services, landscaping and snow removal, and any other appropriate services.
- Develop and maintain relationship with building landlord, resolving issues and concerns between parties as they arise. Support the negotiation and establishment of new or renewed leases.
- Develop, implement and monitor Facilities Engineering budget. Report potential budget issues and take corrective action as necessary to stay within budget.
- Ensure appropriate project management occurs for site and facilities capital projects.
- Provide leadership and oversight for facility upgrades and/or expansions and for new manufacturing site(s). Establish proper oversight and leadership to ensure adherence to proper design to engineering standards, and in the coordination amongst all parties occurs to satisfy all quality and EHS requirements, and to meet timelines and budgetary requirements.
- Collaborate with the MSAT and Pharmaceutical Development Departments to design, implement, and PM/Calibration for technical and automation projects.
- Assure that systems and measures are in place to assure continuity in power supply.
Qualifications:- Bachelor's Degree in Engineering or Life Sciences is required
- 15+ years of experience in biopharmaceutical companies with responsibilities in facilities engineering management of clinical and/or commercial manufacturing facilities is required, with a strong knowledge of GMP guidelines and FDA requirements
- Must be able to read and understand complex electrical, mechanical, HVAC, and automation systems
- Working knowledge of electrical, mechanical and HVAC systems is required
- Demonstrated leadership skills in previous roles
- Impeccable verbal and written communication skills
- Excellent project management skills
- Mobility and ability to lift up to 30 lbs.
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Salary Range
$260,000-$280,000 USD
