Alcami Corporation · 1 day ago
Manager, Facilities and Maintenance
Morrisville, NC
Full-time
Onsite
Mid, Senior Level
6+ years expAlcami Corporation is dedicated to delivering reliable solutions that support transformative medicines from discovery to commercialization. The Manager, Facilities and Maintenance is responsible for overseeing maintenance programs and personnel, ensuring compliance with regulatory requirements, and managing special projects related to facility upgrades and utilities.
Pharmaceuticals
Responsibilities
Provides leadership and direction to the Maintenance (GMP and Facilities)
Plans and manages projects including facility/utility capital projects and other capital efforts
Ensures GMP compliance (e.g. deviation initiation and 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 work order creation, which includes troubleshooting and guidance
Responsible for utilities such as but not limited to HVAC, compressed air, WFI, Clean Steam, nitrogen, chilled water, etc
Manages 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
Directly supervises team of 5-8 direct reports
Participates in the hiring process of other employees
Makes hiring decisions of other employees
Schedules and reviews 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
Other duties as assigned
Qualification
Required
Bachelor's degree (Engineering disciplines) required
6 plus years of regulated (FDA, DEA, NRC, DOE, etc.) applicable experience required
Minimum of 3 years supervisory experience required
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
Preferred
8 to 10 years of regulated (FDA, DEA, NRC, DOE, etc.) applicable experience preferred
Prior pharmaceutical experience preferred; CMO or CDMO experience preferred
Experience in aseptic operations a plus
Company
Alcami Corporation
Alcami is a US-based contract development and manufacturing organization headquartered in NC with 45+ years of experience advancing pharmaceuticals and biologics from development to delivery.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase