The Associate Director of Facilities Engineering will be responsible for leading a group of engineers and technicians to support daily operations, maintenance and repair of facility systems, be actively involved in design and modifications to manufacturing and building support systems, manage the performance of system checks, and maintain validated systems in a state of control and compliance with regulatory requirements. This position will also oversee the planning, budgeting and execution of Facilities Engineering and Facilities Technical group including spare parts program management.
· Manage the facilities team and the execution of the care and maintenance of the Science Center Campus 24/7 cGMP operations, GLP, R&D, and general spaces. Interact closely with key stakeholders in all areas of the campus to provide facilities support for manufacturing, R&D, quality, and general admin departments.
· Partners proactively with other group/function managers with strategic partners (Finance, Procurement, etc.) to support business objectives, streamline business processes impacting project planning/execution, and implement business process changes.
· Provide management of appropriate department expense finances and is accountable for annual budget planning and execution for both facilities engineering and the facilities technical group.
· Be responsible for the 24/7 maintenance and repair for all buildings and equipment, ensuring safe, reliable and cost effective usage.
· Managerial responsibilities include the coaching, guiding, and directing the facility engineering and technical team to ensure overall team performance.
· Incumbent will work with a team to identify opportunities for continuous improvement and pursue changes and upgrades to the systems as warranted.
· He/ she will specify and recommend building equipment modifications to improve safety, reliability and operability of the site facilities.
· He/she will work to ensure that customers, partners and other stakeholders are at all times abreast of key developments, opportunities and risks by driving regular communication and information-sharing.
· Maintain a state of compliance, updating maintenance and operations SOPs for improved schedule alignment and equipment uptime.
· Provide resourcing for advanced technical assistance to site operating groups through investigations, evaluations, specialty studies, control system assessments, and design support.
· Generate and implement corrective action plans for facility system repairs, replacements and modifications.
· Deliver initiatives that provide for the overall goals of the company and engineering department with regards to facility and utility design, standardization and compliance.
· Lead a culture of inclusion and focus on safety and avoidance of job related injuries.
The qualified candidate will possess the following:
· B.S. in Engineering (Chemical, Mechanical, Electrical preferred) or equivalent is required
· Minimum of 15 years’ experience or equivalent in life sciences manufacturing facilities design and operation, including experience in a management role
· Extensive cross-functional team experience, including technical and non-technical work
· Demonstrated pharmaceutical / biotech manufacturing facilities design / operation experience
· Strong technical leadership, collaboration, and sound business value based prioritization and problem solving skills. Excellent interpersonal, leadership and conflict resolution skills will be required, as the role works frequently in a resource challenged and schedule sensitive environment.
· Excellent communication and presentation skills with the ability to effectively communicate ideas, goals, and results to various audiences. Must deliver effective presentations to senior management.
· Contacts with suppliers and outside collaborators will occur at the highest levels in those organizations. Advisor to top management on site directives / strategies.
· Requires ability to mentor, coach and develop staff at various levels of seniority and experience.
· General knowledge requirements include all applicable building codes and related regulations, basic design and construction methodologies, (particularly in the process and mechanical discipline).
· Special knowledge requirements include biopharmaceutical and pharmaceutical processes and facility design approaches, plus a solid understanding of cGMP requirements. Familiarity with common pharmaceutical manufacturing equipment, such as clean room facilities, clean and plant utilities, aseptic bulk and filling equipment, autoclaves / washers, etc.
· Demonstrated knowledge of design / operation / maintenance practices and procedures for equipment such as: boilers, chillers, air handlers, cooling towers, pure steam generators, RO/DI and Water For Injection systems, water distribution equipment, autoclaves, heat exchangers, electrical distribution systems, fire protection systems, clean-in-place systems, emergency generators, etc.
· Incumbent will have previous knowledge of GMP systems and have experience with FDA and / or/ EMA regulatory audits.
· Ability to manage multiple responsibilities with a high degree of self-motivation.
· Ability to organize and present technical and department overviews to upper management and executives.