Maintenance & Engineering Manager

Steri-Pharma; City of Syracuse (NY); On-site; USD 120,000 - 150,000; Full time

Job summary

Steri-Pharma is seeking a Maintenance & Engineering Manager to lead the maintenance organization on the 1st shift. You will drive preventive maintenance strategies, ensure GMP compliance, and manage budgets and SOPs while partnering with operations to meet production needs.

The role requires strong leadership, regulatory knowledge, and the ability to develop maintenance policies. Expect a collaborative, fast-paced environment focused on quality and safety.

Qualifications

• Bachelor’s degree from a regionally accredited institution in engineering or related field.
• At least 5 years’ experience leading and managing maintenance technicians and/or engineers.
• Knowledge of Microsoft Office and general computer applications.
• Expertise in manufacturing, production processes and regulatory requirements for pharmaceuticals.
• Advanced knowledge of production equipment and supporting systems.
• Ability to develop and implement maintenance policies and SOPs.
• Strong safety, GMP compliance, and risk assessment capabilities.

Responsibilities

• Leads the maintenance organization and drives preventive maintenance strategies.
• Supports compliance inspections and regulatory readiness.
• Develops budgets and manages maintenance-related costs.
• Oversees SOPs and document control within maintenance.
• Mentors staff and fosters a safe work environment.

Skills

Maintenance leadership

Project management

Regulatory compliance knowledge

cGMP knowledge

Microsoft Office

Education

Bachelor's degree in engineering

Job description

Maintenance & Engineering Manager, Pharma

Monday-Friday 1st Shift; schedule flexibility required.

Your responsibilities:

• Leads and supports the development of a Maintenance Vision, Mission, Strategies and Goals that provides a guide to becoming an efficient and effective maintenance organization.
• Supports and maintains maintenance metrics to support the benchmarking of site, global and industry.
• Develops improvement strategies based off the benchmarking data.
• Manages the maintenance department that provides technical, project management, emergency response, troubleshooting and preventative maintenance support for facilities, utilities, and process related equipment.
• Functions as a technical expert to equipment or systems regarding troubleshooting operational issues and point of contact during compliance inspections.
• Provides solutions to a variety of technical problems.
• Supports the development of the department budgets.
• Assures the appropriate level of trainings for all levels of the maintenance organization such as cGMP’s, technical, SOP’s and compliance trainings and maintain records for staff.
• Oversees the development, revision, review and approval of Standard Operating Procedures/Job Plans that are owned by the maintenance department.
• Supports project engineering in the justification, prioritization and coordination of manufacturing projects.
• Provides design assistance using knowledge of both the operations and facilities capabilities and the knowledge of production requirements.
• Partners with internal departments and customers to ensure maintenance operational strategies are in alliance with our compliance commitments.
• Maintains an environment that promotes maintenance flexibility, consistent maintenance practices and efficient operations, which prepare for current and future production demands.
• Supervises direct reports in the execution of maintenance and/or utilities operation activities.
• Assures compliance with safety regulations, including safety permits.
• Contributes to the leadership team and engages in business decision making from a Quality perspective.
• Promotes a safe and harmonious work environment.
• Maintains compliance with SOPs, GMPs, and all company policies.

Expectations:

• Projects are completed on time and per documented project plans
• Technicians are well trained, cooperative, work collaboratively, and maintain GMP compliance
• Reports are completed accurately and in a timely manner
• Regulatory visits are planned and executed in a timely and effective manner
• OEE results are analyzed and reported, and improvement plans communicated and implemented
• Values personal competency and the competency of co-workers
• Be receptive to constructive feedback
• Critical documentation to include but not limited to SOPs are accurate, updated and codified, used in a compliant manner, and stored appropriately
• Critical parts are maintained at all times
• Continuously maintains an effective quality and compliance vigilance
• Maintains a work environment that is safe and healthy and meets regulatory standards
• Meets departmental standards
• Meets goals established by your manager
• Attends work as scheduled

You bring these qualities:

• A Bachelor’s degree from a regionally accredited institution in engineering or related field
• At least 5 years’ experience leading and managing maintenance technicians and/or engineers
• Knowledge of general computer functions such as Microsoft Office programs, spreadsheets, etc.
• Knowledge and understanding of processes relevant to the manufacturing and production of regulated products, regulatory and development processes, how regulatory entities approach inspections, responding to regulatory observations, regulatory cGMP requirements for pharmaceuticals, regulatory approval processes, cGMPs and SOPs , regulatory entity inspections requirements, regulatory guidance documents
• Advanced knowledge of production equipment and supporting systems
• Knowledge and skill in identifying, analyzing, and controlling hazards which are significant for product quality and reliability in the manufacturing and supply chain
• Skill in handling several projects or tasks at the same time, or within a given time frame
• Advanced Problem Safety Sensitivity; the ability to recognize a safety issue or potential safety issue
• Skill in quality and compliance vigilanceSkill in creating and implementing a document control system
• Ability to inspect the work of others and coach performance in line with company standard operating procedures
• Ability to apply critical thinking
• Ability to develop a comprehensive maintenance system, including the ability to write policies and SOPs as well as mentor others in writing policies and SOPs
• Ability to effectively articulate and present the company’s maintenance strategy to our employees, senior management, regulatory bodies and customers
• Advanced project management and documentation skills
• Ability to use training/instructional methods and procedures appropriate for the situation and audience
• Ability to instruct/teach one on one on how to perform functions
• Ability to trust, develop, maintain, and strengthen partnerships with others inside the organization who can provide information, assistance, and support
• Ability to lead by example
• Ability to communicate with coworkers, management team members, and other individuals in a courteous and professional manner
• Ability to work in a fast-paced environment
• Ability to pay close attention to detail and coordinate various activities simultaneously

Physical Dimensions:

• Seeing: Must be able to read reports and use computer 75-100% of time
• Hearing: Must be able to hear well enough to communicate with coworkers 75-100% of time
• Standing/Walking/Mobility: Must be able to stand to open files and operate office equipment; mobility between departments and attend meetings of coworkers and management 75-100% of time
• Climbing/Stooping/Kneeling: Must be able to climb, stoop, or kneel to perform routine tasks within the scope of job 25-49% of time
• Lifting up to 50 lbs./ Pulling/Pushing within the scope of job 25-49% of time
• Touching/Grasping/Feeling: Must be able to write, type, and use office equipment; along with handling material and equipment 75-100% of time

About Us:

https://www.steri-pharma.com

Notice of Employee Rights, Protections, and Obligations under Labor Law Section 740: https://dol.ny.gov/system/files/documents/2022/02/ls740_1.pdf

EEOC 'Know Your Rights' Poster: https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12.pdf

Employee Rights Under the Polygraph Protection Act: https://www.dol.gov/sites/dolgov/files/WHD/legacy/files/eppac.pdf