Director of Facilities & Engineering 503A

Job Description

Position Summary

The role of Facilities and Engineering Director is pivotal in shaping our operational excellence and commitment to quality. This position is integral to ensuring our manufacturing facilities operate seamlessly, upholding the highest standards of efficiency and reliability. You will lead a dedicated team, crafting and executing a strategic roadmap that aligns with the mission to produce innovative medications that help people live healthier, happier lives.

Collaborating with cross-functional teams such as Operations and Quality Assurance, you will drive synergy and alignment, ensuring our facilities support the manufacturing process impeccably. Your expertise in Quality Management Systems will be instrumental in maintaining top-tier standards across engineering and maintenance operations. This includes overseeing preventative maintenance programs, ensuring all equipment and systems are maintained and calibrated, and implementing best practices for operational efficiency and safety.

In this role, you will also manage facility projects, from construction to renovation, working closely with contractors and vendors. Your ability to drive continuous improvement, solve technical challenges, and maintain robust facility operations will be key to maximizing manufacturing capabilities and ensuring compliance with industry standards.

Duties and Responsibilities

• Develops and executes a strategic roadmap for Engineering and Facilities, aligning departmental objectives with the company's overall goals.
• Collaborates closely with cross-functional teams, including Operations, Quality Assurance, and other functional areas, to ensure synergy and alignment in supporting the manufacturing process.
• Leads efforts to provide uninterrupted 24x7 support for manufacturing operations, promptly addressing technical challenges in compliance with current Good Manufacturing Practice guidelines.
• Expert in Food and Drug Administration and United States Pharmacopeia guidelines.
• Utilizes in-depth experience with Quality Management Systems, including Change Controls, corrective and preventive actions, failure modes and effects analysis and Deviations, to uphold the highest quality standards across engineering and maintenance operations.
• Provides accurate preventative maintenance forecasting methods with continuous improvement.
• Develops schedule for preventative maintenance, major projects, and facility modifications. Coordinates shutdowns with operational management to ensure the availability of resources for timely completion to maximize manufacturing capability.
• Implements changes for improving manufacturing line efficiencies and maintenance performance.
• Develops and monitors calibration program to meet operational goals.
• Ensures that all facility equipment is properly maintained, calibrated, qualified, and validated.
• Ensures that all areas and equipment are maintained in Good Housekeeping condition.
• Implement best practices in the operation, maintenance, and troubleshooting of the following systems: Low Pressure Boilers, Plumbing, HVAC, Electrical, Reverse Osmosis / Deionization (RO/DI), Building Management System.
• Interacts with and manages contractors for construction, renovation, validation, etc. as required.
• Coordinates with material/equipment vendors.
• Drives continuous improvement by managing projects and recommending techniques to enhance equipment, system, and process robustness and maintain the facility in peak condition.
• Carries out safety assessments for modifications to equipment.
• Responsible for facility security and access control systems.
• Develops and delivers ongoing training to employees regarding utilities equipment and hazards.
• Utilizes facility engineering principles to solve straight forward problems.
• Works with production daily to coordinate appropriate courses of action to maximize uptime and quality performance of respective area.
• Interfaces with operations management to complete requested facility projects in a timely manner.
• Manages Engineering and facility budgets, including forecasting, planning, and monitoring expenses.
• Fosters a collaborative and innovative work environment, encouraging creativity and continuous improvement within the team.
• Provides mentorship and professional development opportunities to the team, supporting their growth and success within the organization.
• Develops and establishes key performance indicators to assess the success of the department and its employees.
• Evaluates employee performance, provides feedback and coaching/corrective action as needed. Prepares annual performance evaluations for employees.
• Stays up to date on industry trends, best practices, and emerging technologies incorporating innovative ideas.
• Partners with department leadership to evaluate headcount needs.
• Maintains records showing compliance with all federal, state, and local safety, environmental requirements such as permits, inspection documents, training/certifications, etc.
• Performs other duties as assigned.

While performing the responsibilities of the job, the employee is required to talk and listen. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices. The employee is regularly required to move about the office and around the corporate campus. The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl. Vision abilities required by this job include close vision. Employees must be able to lift 30 lbs.

Knowledge and Skills

• Expertise in operation and troubleshooting/repair of utilities such as HVAC, high purity water, and process heating/cooling.
• Ability to cope with varied levels of workload and multiple tasks.
• Must be able to work in a fast paced and changing environment.
• Strong time management and organizational skills.
• Willingness to be a team player and promote a positive team environment.
• Excellent attention to detail.
• Flexible and proactive to meet varied company needs.
• Self-motivated and able to work independently.
• Strong interpersonal and people skills.

Key Competencies

• Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions.
• Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement.
• Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives.
• Resourcefulness: Secures and deploys resources effectively and efficiently.
• Manages Complexity: Makes sense of complex, high quality, and sometimes contradictory information to effectively solve problems.
• Ensures Accountability: Holds self and others accountable to meet commitments and objectives.
• Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations.
• Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences.