Manager, Engineering

Be the First to Apply Division Piramal Pharma Solutions Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide. For more details, please visit : www.piramalpharmasolutions.com Job Title Manager, Engineering Job Description Piramal Pharma Solutions’ HPAPI Research and Manufacturing facility (Ash Stevens, LLC), located in Riverview, Michigan, is seeking a qualified Manager, Engineering. The Manager, Facilities & Engineering is responsible for ensuring the reliability, compliance, safety, and operational readiness of site facilities, utilities, and manufacturing equipment within a GMP pharmaceutical manufacturing environment. The position leads a multidisciplinary engineering organization responsible for project engineering, process engineering support, validation engineering, calibration, instrumentation & controls, facility engineering, and technical troubleshooting. The Manager, Facilities & Engineering develops and executes the site capital plan, ensures the effectiveness of maintenance and reliability programs, supports regulatory and customer audits, and provides engineering leadership to enable safe, compliant, and efficient manufacturing operations. Engineering support for new customer projects is focused on facility readiness, utility capacity, equipment suitability, containment considerations, materials of construction, and qualification requirements. Key responsibilities. Leadership & Organizational Development Lead, mentor, and develop a multidisciplinary engineering team. Establish departmental objectives , priorities, and performance metrics. Develop engineering succession plans and organizational capability. Allocate engineering resources across manufacturing support, capital projects, validation activities, and continuous improvement initiatives. Serve as the engineering representative on site leadership teams. Provide engineering leadership for process safety, containment systems, and mechanical integrity programs supporting HPAPI and API manufacturing operations. Conduct performance management, coaching, development planning, and talent assessment activities for engineering personnel Facilities, Utilities & Infrastructure Provide technical ownership of site facilities and utility systems. Ensure facility and utility systems are maintained in a compliant and reliable state. Support facility expansion, renovation, and infrastructure improvement projects. Maintain long-range plans for facility and utility capacity to support business growth. Ensure utility systems are capable of supporting current and future manufacturing requirements. Equipment Reliability & Asset Management Establish and maintain equipment reliability programs. Develop maintenance strategies that maximize equipment uptime and performance. Ensure preventive and predictive maintenance programs are effective and risk based. Lead investigations and root cause analyses for significant equipment failures. Develop life-cycle plans for critical manufacturing assets. Ensure appropriate spare parts and obsolescence management strategies are maintained . Engineering Project Management Develop and maintain the site capital investment plan. Prepare project justifications, scope documents, budgets, and capital requests. Manage engineering projects from concept through commissioning and qualification. Ensure projects are executed safely, on schedule, within budget, and in compliance with site requirements. Coordinate engineering activities with manufacturing, quality, validation, and supply chain organizations. Own the engineering operating budget and capital expenditure budget, ensuring effective allocation of resources and achievement of financial objectives . Develop and maintain the site facilities master plan to support current operations and future business growth. Validation & Engineering Compliance Ensure engineering systems, equipment, and utilities are appropriately qualified and maintained in a validated state. Review and approve engineering-related validation documentation. Support deviation investigat