Position Summary

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.

Essential Functions

• 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 systems 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.

Alcami Non-Negotiables

• 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.

Functional Competencies

• 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 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.

Supervisory Responsibilities

• Directly supervises team of 5-8 direct reports.
• Participates in the hiring process of other employees.
• Makes hiring decisions of other employees.
• Schedules and review the work of other employees.
• Accountable for the curriculum assigned and timely completion of training of employees to meet regulatory requirements.
• Coaches, mentors and develops other employees.
• Prepares and delivers performance evaluations of other employees.
• Make recommendations 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.

Travel Requirements

Up to 10% of domestic travel

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is required to frequently talk or hear. The employee is required some of the time to stand, walk, and sit. The employee is required to occasionally use hands to finger, handle, or feel; climb or balance; stoop, knell, crouch or crawl; reach with hands and arms; taste or smell. The employee must regularly lift and/or move up to 10 pounds, occasionally lift and/or move up to 50 pounds. There is no special vision requirement for this job. The employee may occasionally work in wet or humid conditions, near moving mechanical parts, in high precarious places, near fumes, airborne particles or toxic chemicals.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.