The Manager, Maintenance and Facilities for our parenteral site in Charleston, SC 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 at Alcami, such as FDA, DEA, and EU as examples. The position requires strong leadership behaviors of the Alcami 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.
Education and Experience
Bachelor's degree (Engineering disciplines) required.
2-5 years of regulated (FDA, DEA, NRC, DOE, Etc.) applicable experience required; 5-8 years preferred.
Minimum of 3 years supervisory experience required.
Prior pharmaceutical experience required; CMO or CDMO experience preferred.
Experience in aseptic operations a plus.
Consistently demonstrates honesty and integrity through personal example.
Follows all safety policies and leads by example a safety first culture.
Produces high quality work product with a focus on first time right.
Complies with the company code of conduct and policies and regulatory standards.
Alcami Core Leadership Competencies
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.
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.
Excellent ability to read and interpret engineering design, ability to read and understand equipment specifications, and ability of track and trend data analysis required.
Good negotiating skills required.
Ability to manage a Maintenance team that works multiple shifts.
Directly supervises team of 7 direct reports.
Participate in the hiring process of other employees.
Make hiring decisions of other employees.
Schedule and review the work of other employees.
Accountable for the curriculum assigned and timely completion of training of employees to meet regulatory requirements.
Coach, mentor and develop other employees.
Prepare and deliver performance evaluations of other employees.
Make recommendation of disciplinary actions of other employees.
Decision Making and Supervision Required
Uses professional concepts and company policies and SOPs to solve a broad range of difficult problems.
Independently determines methods and procedures, including assignments and the work of others.
What We Offer You:
Competitive salary with career advancement opportunities
Profit sharing bonus plan
Medical, dental and vision coverage from day one
401(k) with company match
Company paid vacation, holiday and sick-leave
Voluntary benefits including short & long term disability, life, accident, critical illness insurances