Associate Director, Maintenance

🔥 13 minutes ago

🦀 Maryland – Remote

🦀 Maryland – Remote

💵 $174k - $203k / year

⏰ Full Time

🟠 Senior

👔 Director

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Lonza

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1897

🧬 Biotechnology

💊 Pharmaceuticals

🏭 Manufacturing

💰 $444.8M Post-IPO Debt - Lonza on 2023-11

Biotechnology • Pharmaceuticals • Manufacturing

Lonza is a Swiss-based, global contract development and manufacturing organization (CDMO) and life sciences company. It provides integrated end-to-end offerings across biologics and small-molecule drug development and manufacturing — including cell line development, process and analytical development, formulation and primary packaging, drug substance and drug product manufacturing, and regulatory/CMC support. Lonza's capabilities span advanced synthesis and APIs (including HPAPIs), bioconjugation and ADCs, specialized modalities such as cell & gene therapies, mRNA/LNP, microbial processes, and capsule and health-ingredient products. Founded in Switzerland in 1897, Lonza describes itself as a pioneer and world leader in the CDMO industry and operates with ~20,000 colleagues across five continents to support pharmaceutical and biotech customers.

📋 Description

• Lead maintenance and reliability readiness activities for a U.S. growth investment project. • Ensure the facility, equipment, utilities, process equipment, and maintenance systems are designed and implemented with long-term reliability, maintainability, mechanical integrity, and GMP compliance in mind. • Work closely with Engineering, Operations, Automation, MSAT, and Quality to establish the maintenance organization, systems, and processes required for successful site start-up and ongoing operations. • Provide maintenance and reliability leadership throughout facility design, construction, commissioning, qualification, and start-up activities. • Develop maintenance strategies, including preventive, predictive, and reliability-centered maintenance programs to support long-term asset performance. • Partner with Engineering and project teams to ensure maintainability, serviceability, accessibility, and lifecycle considerations are incorporated into facility and equipment design. • Establish asset lifecycle management strategies, including spare parts plans, calibration programs, and equipment reliability initiatives. • Support the selection, implementation, and optimization of CMMS and other maintenance technologies to enable effective planning and execution. • Participate in commissioning, qualification, FAT/SAT, and operational readiness activities to ensure maintenance requirements are incorporated and validated. • Define the future maintenance organization, including staffing plans, training requirements, operating procedures, and site support models. • Identify and mitigate equipment reliability, maintenance, and operational readiness risks while providing updates and recommendations to project leadership.

🎯 Requirements

• Bachelor’s degree in engineering, Facilities Management, Reliability Engineering, or a related technical discipline; advanced degree preferred. • 10+ years of experience in maintenance, reliability, engineering, or technical operations within pharmaceutical or API manufacturing environments. • Experience with HPAPI, complex chemical synthesis, or chemical process manufacturing is preferred. • Experience supporting major capital projects, facility start-ups, manufacturing expansions, greenfield or brownfield investments, or large-scale operational readiness initiatives. • Strong knowledge of maintenance best practices, reliability engineering, asset lifecycle management, and equipment performance improvement. • Experience with CMMS platforms, predictive maintenance technologies, reliability-centered maintenance (RCM), and maintenance planning systems. • Understanding of GMP requirements related to equipment maintenance, calibration, qualification, documentation, and inspection readiness and mechanical integrity principles. • Demonstrated experience supporting small molecule drug substance, API, or HPAPI manufacturing operations preferred. • Experience supporting containment-intensive manufacturing environments (e.g., HPAPI containment, isolators, contained material handling) preferred. • Experience within a multi-product API manufacturing or CDMO environment is preferred. • Strong leadership, communication, collaboration, and problem-solving skills with the ability to influence cross-functional teams and stakeholders. • Ability and willingness to transition to an East Coast or Midwest U.S. site location as project needs evolve. • Willingness and ability to travel to EMEA and NA at approximately 25-30% of the time to meet business objectives.

🏖️ Benefits

• Performance-related bonus. • Medical, dental and vision insurance. • 401(k) matching plan. • Life insurance, as well as short-term and long-term disability insurance. • Employee assistance programs. • Paid time off (PTO).