Technical Support Manager

Overview: <ul><li>The Technical Support Manager leads a team of skilled mechanics and technicians responsible for the maintenance, troubleshooting, and reliability of facility infrastructure, clean utilities, laboratory systems, and pharmaceutical production equipment at our new injectable manufacturing site.&nbsp;</li><li>This individual will play a key leadership role in coaching, mentoring, and developing technical staff, while ensuring all maintenance activities are performed safely, efficiently, and in compliance with cGMP and regulatory requirements.&nbsp;</li><li>This is a pivotal role in a startup manufacturing environment, requiring strong leadership, technical depth, and a commitment to operational excellence and safety. During the start up phase this role will include the development of an asset management system and the development of standard operating procedures for the maintenance and calibration of systems across the plant.</li></ul> Responsibilities: <ul><li>Supervise and develop a team of mechanics and technicians supporting facilities, utilities, lab and production equipment. Additional oversight of contractors will be expected.</li><li>Coach, train, and mentor team to build technical depth and promote a culture of ownership and continuous improvement.</li><li>Lead the development of standard operating procedures as required.&nbsp;&nbsp;</li><li>Champion the start up and maintenance of an asset management system that will become the basis of technical support in the plant.&nbsp;&nbsp;</li><li>Lead daily planning, prioritization, and execution of maintenance and reliability activities.&nbsp;</li><li>Conduct performance reviews, skill assessments, and development planning for direct reports.</li><li>Lead the maintenance, calibration, and repair of critical systems including: HVAC, compressed air, WFI, clean steam, Nitrogen generation, isolators, fillers, automated inspection and leak detection equipment, automated secondary packaging equipment, lab systems, stability chambers, site infrastructure, and the Building Management System (BMS).</li><li>Ensure all activities are conducted in compliance with cGMP, safety regulations, maintenance plans and SOPs.</li><li>Support commissioning, qualification (IQ/OQ/PQ), and startup activities for new systems and equipment.</li><li>Drive proactive and preventive maintenance through and asset management system utilization and performance tracking.</li><li>Ensure good documentation practices and data integrity so all maintenance records are accurate, complete, and auditable.</li><li>Enforce a culture of safety focusing on EHS compliance, including Lockout/Tagout, confined space entry, Arc flash protection, and chemical safety protocols.</li><li>Support audits and inspections by regulatory agencies and internal quality teams.</li><li>Analyze equipment performance and maintenance data to identify trends, root causes, and opportunities to reduce downtime and increase reliability.</li><li>Collaborate with engineers, production, and quality teams to improve reliability and maintainability of equipment.</li><li>Manage spare parts strategy and implement inventory management process.&nbsp;</li></ul> Key Stakeholders: Internal: <ul><li>Site Leadership Team (Operations, Quality, Engineering, Warehouse, HR, Finance, EHS)</li><li>Manufacturing Teams</li><li>Validation and Project Management Teams</li></ul> External: <ul><li>FDA and other regulatory agencies</li><li>Third-party auditors and certifying bodies</li><li>External service providers such as calibration and maintenance service companies</li><li>Customers and business partners</li></ul> Requirements: Qualifications / Experience: <ul><li>Bachelor’s degree in engineering is required. Degree in Mechanical, Electrical, Biomedical, or similar preferred.</li><li>Minimum 5+ years of experience in pharmaceutical, biotech, or regulated manufacturing environment, with 2+ years in a supervisory or team lead role.</li><li>Strong technical knowledge of clean utilities, facility systems, secondary packaging and aseptic manufacturing equipment.</li><li>Experience supervising or mentoring maintenance personnel.</li><li>Experience working with a qualified asset management system.&nbsp;(Current system is SAP PM)</li><li>Experience in controlled substance and high potent product environment desired but not required.</li></ul> Skills / Competencies: <ul><li>Working knowledge of cGMPs, regulatory expectations, and CMMS systems (e.g., Blue Mountain, SAP PM, Maximo, etc.)</li><li>Strong organizational, communication, and leadership skills.</li><li>Demonstrated commitment to safety, compliance, and team development.</li><li>Excellent interpersonal, communication, and problem-solving skills.</li><li>Comfortable working in a fast-paced, evolving environment where agility and adaptability are key.</li><li>Strong leadership presence with demonstrated ability to build high-performing teams and compliance culture.</li><li>Effective communication, collaboration, and influencing skills across multiple stakeholders.</li></ul>

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