Maintenance & Engineering Manager

Mai ntenance & 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 vigilance Skill 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_Know. Your. Rights6.12.pdf Employee Rights Under the Polygraph Protection Act: https://www.dol.gov/sites/dolgov/files/WHD/legacy/files/eppac.pdf