Engineering And Maintenance Manager

About the jobWe are seeking an experienced Maintenance & Engineering Manager to lead all maintenance, facilities, utilities, engineering, automation, and continuous improvement activities within our pharmaceutical manufacturing operation.This leadership role is responsible for ensuring the reliability, safety, compliance, and performance of production equipment, utilities, facilities, and infrastructure while driving engineering excellence across the site. You are equally comfortable leading teams on the manufacturing floor, troubleshooting critical equipment issues, and partnering with executive leadership on long-term strategic initiatives.Key Responsibilities Team Leadership, Maintenance Operations and ReliabilityLead and develop maintenance teams composed of Maintenance Technicians and Engineers, responsible for production equipment maintenance and troubleshooting and Building and facility systemsEstablish performance expectations, accountability measures, and development plans for employees.Manage departmental budgets, vendor relationships, and external service providers.Oversee maintenance planning, work order management, scheduling, prioritization, and contractorEstablish and manage robust preventive, predictive, and corrective maintenance programs.Automation & Process Improvement Drive initiatives aiming to improve automation and control systems and upgrade equipment performance Lead continuous improvement opportunities to improve throughput, reduce downtime, increase yield, and eliminate waste.Lead and support capital projects from concept through implementation, including: -Equipment selection and specification -Installation and commissioning -Qualification and validation supportCompliance, Quality and Regulatory Readiness Ensure all maintenance and engineering activities comply with: Current Good Manufacturing Practices (cGMP), FDA and global regulatory requirements, Company quality systems, OSHA and environmental regulationsMaintain compliant documentation including: SOPs, Maintenance records, Equipment logs and work ordersParticipate in internal audits, customer audits, and regulatory inspections.Support deviations, investigations, root cause analyses, CAPAs, and change control activities.Foster a culture of quality, compliance, and inspection readiness.Strategic PlanningAnalyze reliability metrics, equipment performance data, downtime trends, and maintenance KPIs.Develop long-term maintenance, engineering, and asset management strategies aligned with business objectives.Support facility expansion projects, capacity planning initiatives, and future automation programs.Recommend investments that improve reliability, performance, quality, compliance, and cost effectiveness.Required Experience and EducationBachelor's degree in Engineering, Computer Science, Industrial Technology, or related technical discipline; or equivalent combination of education and relevant technical certifications.Minimum of 5 years of progressive maintenance leadership experienceExperience with sterile manufacturing, aseptic processing, cleanrooms, controlled environments, or biotechnology operations.Technical Skills Strong mechanical, electrical, controls, and process engineering knowledge.Expertise in maintenance systems, reliability programs, and equipment lifecycle management.Experience with PLCs, automated manufacturing systems, and industrial controls.Strong understanding of OSHA, GMP, quality systems, and risk management principles.Leadership Profile We are seeking a hands-on, results-oriented leader who:Demonstrates leading by example and is comfortable working on the manufacturing floor, but also coaching and developing multidisciplinary teams Demonstrates strong business acumen and is able to translate technical issues, risks and opportunities to the board roomBalances operational urgency with long-term strategic thinking.Excels in fast-paced, highly regulated environments.Inspires accountability, ownership, and continuous improvement.Why join Assure Infusions?This is an opportunity to play a pivotal leadership role in a growing pharmaceutical manufacturing organization where quality, compliance, innovation, and operational excellence are at the heart of everything we do. You will have the opportunity to influence site strategy, build high-performing teams, and drive meaningful improvements that directly impact patients and the future success of the organization.We are an Equal Opportunity Employer and make employment decisions based on qualifications, merit, and business needs. We are committed to creating an inclusive workplace and do not discriminate on the basis of race, color, religion, sex, pregnancy, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.This position is being recruited and filled directly by the Company. We are not accepting unsolicited resumes from staffing agencies, recruiters, or search firms. Any resumes submitted without a fully executed agreement and written authorization from the Company will become the property of the Company, and no fee will be paid.