Alcami Corporation
Manager, Facilities and Maintenance
Alcami Corporation, Morrisville, North Carolina, United States, 27560
Manager, Facilities and Maintenance
Location: US-NC-Morrisville
ID: 2025-1640
Overview At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team?
Job Summary The Manager, Facilities and Maintenance 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, and critical utilities, as well as general facility utilities. This includes routine day-to-day operations as well as special projects, including customer-centric projects, plant shutdowns, and facility upgrades, renovations, or expansions. The role requires development of project plans, schedules, and oversight of work during execution, in compliance with regulatory requirements of the pharmaceutical industry (e.g., FDA, DEA, EU, etc.).
On-Site Expectations
100% on-site position.
1st Shift: Monday - Friday, 8:00am - 5:00pm.
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 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, maintaining the key control list, and working with the Global Security Manager on 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 through effective selection, training and development, coaching and mentoring, and performance management.
Directly supervises a team of 5-8 direct reports.
Participates in the hiring process of other employees and makes hiring decisions.
Schedules and reviews the work of other employees; accountable for training curriculum and timely completion of training to meet regulatory requirements.
Coaches, mentors and develops other employees; prepares and delivers performance evaluations; makes recommendations for disciplinary actions as needed.
Other duties as assigned.
Qualifications
Bachelor's degree (Engineering disciplines) required.
6+ years of regulated (FDA, DEA, NRC, DOE, etc.) applicable experience required; 8-10 years preferred.
Minimum of 3 years supervisory experience required.
Prior pharmaceutical experience required; CMO or CDMO experience preferred.
Experience in aseptic operations a plus.
Knowledge, Skills, and Abilities
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 requirements.
Excellent written and verbal communication, coaching and mentoring skills.
Ability to read and interpret engineering designs, equipment specifications, and to track and trend data analysis.
Good negotiating skills.
Ability to manage a Maintenance team that works across multiple shifts.
Travel Expectations
Up to 10% 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 to stand, walk, and sit. The employee may occasionally climb, balance, kneel, crouch or crawl; reach with hands and arms; taste or smell. The employee must regularly lift and/or move up to 10 pounds, occasionally up to 50 pounds. There is no special vision requirement. 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.
#J-18808-Ljbffr
Overview At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team?
Job Summary The Manager, Facilities and Maintenance 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, and critical utilities, as well as general facility utilities. This includes routine day-to-day operations as well as special projects, including customer-centric projects, plant shutdowns, and facility upgrades, renovations, or expansions. The role requires development of project plans, schedules, and oversight of work during execution, in compliance with regulatory requirements of the pharmaceutical industry (e.g., FDA, DEA, EU, etc.).
On-Site Expectations
100% on-site position.
1st Shift: Monday - Friday, 8:00am - 5:00pm.
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 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, maintaining the key control list, and working with the Global Security Manager on 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 through effective selection, training and development, coaching and mentoring, and performance management.
Directly supervises a team of 5-8 direct reports.
Participates in the hiring process of other employees and makes hiring decisions.
Schedules and reviews the work of other employees; accountable for training curriculum and timely completion of training to meet regulatory requirements.
Coaches, mentors and develops other employees; prepares and delivers performance evaluations; makes recommendations for disciplinary actions as needed.
Other duties as assigned.
Qualifications
Bachelor's degree (Engineering disciplines) required.
6+ years of regulated (FDA, DEA, NRC, DOE, etc.) applicable experience required; 8-10 years preferred.
Minimum of 3 years supervisory experience required.
Prior pharmaceutical experience required; CMO or CDMO experience preferred.
Experience in aseptic operations a plus.
Knowledge, Skills, and Abilities
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 requirements.
Excellent written and verbal communication, coaching and mentoring skills.
Ability to read and interpret engineering designs, equipment specifications, and to track and trend data analysis.
Good negotiating skills.
Ability to manage a Maintenance team that works across multiple shifts.
Travel Expectations
Up to 10% 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 to stand, walk, and sit. The employee may occasionally climb, balance, kneel, crouch or crawl; reach with hands and arms; taste or smell. The employee must regularly lift and/or move up to 10 pounds, occasionally up to 50 pounds. There is no special vision requirement. 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.
#J-18808-Ljbffr