The Maintenance and Facilities Manager is accountable for driving results in a fast-paced environment by managing and overseeing the programs and personnel related to maintenance of the facility, process equipment, critical utilities, general facility utilities, and site metrology. This includes routine support of day-to-day operations as well as special projects. Special projects include customer centric projects, plant shutdowns, and facility upgrades, renovations or expansions. The Manager, Maintenance and Facilities administers these programs and projects by means of developing project plans, schedules, and oversight of the work during execution. All activities are conducted under the regulatory agency requirements of the pharmaceutical industry and related products that are manufactured, such as FDA, DEA, and EU as examples. The position requires strong leadership behaviors of the core competencies and non-negotiables, as well as the functional competencies of this profile.
- Provides leadership and direction to the Maintenance (GMP and facilities) and Metrology teams.
- Plans and manages projects including facility/utility capital projects and other capital efforts.
- Ensures GMP compliance (e.g. deviation review, CAPA assignments, compliance reports, change control generation and review).
- Provides maintenance program oversight (preventative maintenance programs, repairs, spare parts program, pest control program, etc).
- Reviews and provides oversight to the facilities maintenance and metrology work order creation, which includes troubleshooting and guidance.
- Responsible for utilities such as but not limited to HVAC, compressed air, WFI, Pure Steam, nitrogen, chilled water, etc.
- Provides support as required during bi-annual shutdowns.
- Owns site security, including maintaining the camera and badge reader system at the site, maintaining the key control list and working with the Global Security Manager on implementation of security programs and site security plan.
- Maintains and broadcasts key metrics to management.
- Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
- Attracts, develops, and retains a high performing team to meet the current and evolving needs of the business through effective selection, training and development, coaching and mentoring and performance management.
- Bachelor’s degree (Engineering disciplines) required.
- 2+ years of regulated (FDA, DEA, NRC, DOE, Etc.) applicable experience required; 5-8 years preferred.
- Minimum of 3 years supervisory experience required.
- Must have experience supervising team of 7 direct reports.
- Prior pharmaceutical experience required; CMO or CDMO experience preferred.
- Experience in aseptic operations a plus.
- Expert knowledge of pharmaceutical facility operations and maintenance, and aseptic processing equipment.
- Knowledge of FDA regulated industry requirements, work order/calibration software, managing personnel, and EHS required.
- Excellent written and oral communication, coaching, and mentoring staff skills required.
- Thinks strategically. Quickly identifies and acts on opportunities. Considers the downstream impact. Seeks to understand the why. Focuses on work that matters.
- Develops organization and others. Takes ownership to develop self and others. Seeks out new opportunities and experiences for continuous learning.
- Acts decisively. Makes and acts on decisions quickly. Makes decisions with the customer and their patients in mind. Meets commitments with a sense of urgency. Seeks ways to be more efficient.
- Drives performance. Holds self and others accountable. Delivers results first time right. Never settles for status quo. Willing to have tough conversations. Asks for feedback and takes action to improve.
- Passion for customers. Listens to understand. Asks the right questions. Gets to the heart of the matter and uses that insight to provide value.
- Works collaboratively. Seeks out the experience of others with the aim for better results. Open minded regardless where ideas originate. Flexible and easy to work with.
Kelly puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering talent and services since 1965. And engineering job seekers know Kelly as a firm with an unmatched reputation for quality, integrity, and professionalism. Whether you seek the variety and flexibility of working on short-term project engagements or prefer contract-to-hire or direct-hire placement with our clients, apply with Kelly to explore opportunities that suit your specific professional interests.
At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
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