Merck
Wilmington (Biotech), DE
Shift: Full time
Job Description Position Summary: The Manufacturing Automation Manager of Lab Digital Support Operations is responsible for leading a team of FTEs and contractors, delivering high-quality IT support for lab operations. This role oversees team development, performance management, and strategic goal setting, ensuring alignment with both site and corporate objectives. The ideal candidate will combine technical expertise with strong leadership and communication skills, fostering a culture of continuous improvement, diversity, and inclusion within the Lab IT team. Key Responsibilities Leadership Team Management: Lead, mentor, and develop a team of FTEs and contractors, fostering a culture prioritizing diversity, inclusion, safety, quality, and compliance. Build strong collaborative relationships between Lab IT and other departments including QC and Manufacturing. Provide clear direction, establish high standards, and assess team performance to deliver top-tier Lab IT support. Conduct regular performance evaluations and provide constructive feedback to team members. Strategic Planning Goal Setting: Establish goals and KPIs for the Lab IT team, ensuring alignment with QC, manufacturing, site and corporate objectives. Drive continuous improvement initiatives across the Lab IT landscape to achieve year-on-year productivity gains. Identify opportunities for process improvements and lead initiatives to enhance operational efficiency. Operational Excellence Issue Resolution: Monitor key metrics and ensure timely closure of safety, quality, and compliance actions, including QNs, CAPAs, and Change Controls. Ensure audit readiness for lab IT systems, particularly in areas related to quality metrics. Develop and manage budgets, maintaining operational efficiency. Technology Integration Reliability: Collaborate with the business to ensure all lab equipment purchases align with IT standards and integrate seamlessly with our infrastructure. Maintain Lab IT systems’ reliability, enhancing efficiency through technology. Oversee Lab system validation and ensure all changes, including security patches, are properly assessed for software compatibility. Stay current with Lab IT trends and technologies, recommending new solutions and improvements. Collaboration Standardization: Coordinate with regional and global teams to standardize processes and procedures across lab IT systems. Collaborate with cross-functional teams to troubleshoot and resolve automation-related issues promptly. Stakeholder Engagement Change Management: Manage vendor relationships, ensuring their services meet quality and contractual obligations. Lead stakeholder engagement to manage IT change initiatives effectively and communicate priorities clearly. Strategically influence cross-functional teams and senior leadership to advance Lab IT goals. Qualifications Education Minimum Requirements : Bachelor’s degree in engineering, information technology, or a related field. Preferred Skills Experience: Minimum of 5 years of experience in digital systems within a manufacturing environment Experience supporting digital laboratory systems and applications in a GMP regulated environment (R D, QC, Analytical, or Development labs). Strong understanding of laboratory informatics ecosystems, including Laboratory Information Management Systems (LIMS), Chromatography Data Systems (CDS), and instrument integration platforms (e.g., Empower, LabWare, LabX, or equivalent), supporting data integrity, compliance, and laboratory operations Working knowledge of laboratory analytical instrumentation and COTS platforms, with experience in HPLC, UV, FTIR, spectrophotometers, titrators, balances, and the supporting vendor software ecosystems Experience with integrating lab instruments and applications with enterprise systems (e.g., LIMS, ELN, data historians, SDC, Scitara, Biovia , MES or reporting platforms). In‑depth understanding of the System Development Life Cycle (SDLC) for regulated systems, including requirements, design/configuration, testing, validation, release/change control, and maintenance. Working knowledge of IT/OT standards, cybersecurity, and infrastructure considerations for lab environments (PC‑based and non‑PC instruments). Excellent problem-solving skills and the ability to think strategically. Strong interpersonal and communication skills, with the ability to influence and collaborate effectively. This role provides a unique opportunity to shape the digital transformation of lab operations at our company, driving innovation and operational excellence. Required Skills: Audit Management, Budgeting, Business Process Improvements, Cybersecurity, Data Management, Driving Continuous Improvement, GMP Compliance, Laboratory Information Management System (LIMS), Manufacturing Environments, Operational Excellence, Problem Management, Quality Management, Real-Time Programming, Software Development Life Cycle (SDLC), Stakeholder Engagement, Strategic Planning, Systems Developmen