Computer System Validation Manager Jobs in Maryland

Director, Automation

Location: This position is currently remote. A future transition to an on-site location on the U.S. East-Coast/Mid-West is anticipated as the project progresses, with an expected timeline in 2027. This is a full-time role with a Monday-Friday schedule from 8:00 a.m. to 5:00 p.m.

What you will get:

The full-time base annual salary for this position is expected to range between $203,400 to $237,300. In addition, below you will find a comprehensive summary of the benefits package we offer:

• 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).

Compensation for this role will be determined by the candidate's qualifications, skills, experience, and relevant knowledge.

What will you do:

We are seeking a Director, Automation Lead to develop and execute the automation, digital systems, and operational technology (OT) strategy for an assigned U.S. growth investment project supporting small molecule drug substance manufacturing. This role serves as the primary automation leader throughout facility design, construction, commissioning, qualification, validation, start-up, and operational handover, ensuring systems are reliable, compliant, scalable, and ready to support GMP manufacturing from day one.

• Lead the automation workstream for an assigned U.S. growth investment project, ensuring alignment with project milestones, operational requirements, and GMP expectations

• Define the automation strategy, architecture, and digital manufacturing roadmap, including control systems, system integration, data flows, historians, MES, and reporting solutions

• Partner with Engineering, Manufacturing, MSAT, Quality, IT/OT, CSV, and EHS teams to ensure automation requirements are incorporated into facility, process, and equipment design

• Provide leadership for automation-related commissioning, qualification, computer system validation (CSV), and start-up readiness activities

• Manage automation vendors, system integrators, and external partners to ensure quality execution, on-time delivery, and effective risk management

• Ensure automation systems meet regulatory, GMP, data integrity, cybersecurity, and lifecycle management requirements

• Identify and mitigate automation, digital, and operational technology risks while providing strategic recommendations to project leadership and governance teams

• Establish the long-term automation support model, including organizational capability, training, knowledge transfer, and operational handover to the future site team

What we are looking for:

• Bachelor's degree in Automation Engineering, Electrical Engineering, Computer Science, Chemical Engineering, Life Sciences Engineering, or a related technical discipline; advanced degree preferred

• 12+ years of experience leading automation, OT, or digital manufacturing initiatives within pharmaceutical, API, biotechnology, chemical, or other GMP-regulated manufacturing environments

• Experience supporting major capital investment projects, facility start-ups, greenfield or brownfield expansions, or large-scale manufacturing transformations

• Strong knowledge of automation platforms, system integration, manufacturing execution systems (MES), SCADA/DCS/PLC technologies, and digital manufacturing solutions, and batch process control architectures

• Demonstrated experience supporting small molecule drug substance or API, HPAPI, or complex chemical process manufacturing operations, including commissioning, qualification, validation, and commercial manufacturing readiness

• Strong understanding of GMP regulations, Computer System Validation (CSV), GAMP 5 principles, data integrity requirements, and industrial cybersecurity standards

• Proven ability to lead cross-functional teams and influence stakeholders across Engineering, Manufacturing, Quality, IT/OT, MSAT, EHS, and Project Management organizations

• Excellent communication, strategic planning, vendor management, and problem-solving skills, with experience presenting to senior leadership and project governance teams

• Experience with ISA-88, ISA-95, and ISA/IEC 62443 frameworks, and batch process automation

• Experience supporting multi-product API manufacturing or CDMO environments is preferred.

• Experience integrating DCS, PLC, MES, historians, and enterprise systems across complex batch manufacturing facilities is preferred.

• PMP, GAMP, automation, or related technical certifications

• Experience supporting highly automated API, chemical, or small molecule manufacturing facilities

• Ability and willingness to transition to an East Coast or Midwest U.S. site location as project needs evolve

• Travel: Willingness and ability to travel to EMEA and NA at approximately 25-30% of the time to meet business objectives

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone's ideas, big or small, have the potential to improve millions of lives, and that's the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you're ready to help turn our customers' breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Ready to shape the future of life sciences? Apply now