Senior Validation Engineer - CSV (OT)

Lonza Group Ltd.; Vacaville (CA); On-site; Confidential; Full time

Benefits offered by this job

Performance-related bonus

Medical, dental and vision insurance

401(k) matching plan

Life insurance, plus short-term and长期注

Employee assistance programs

Paid Time Off

Job summary

Lonza Vacaville is seeking a Senior Validation Engineer - CSV in Vacaville, California, a fully site-based role that supports close, real-time collaboration and the high-precision manufacturing of medicines in a regulated environment.

The role leads validation of processes, equipment, and computerized systems with strong cGMP, FDA, EMA knowledge; you will drive risk-based validation and coordinate cross-functional teams across Engineering, MSAT, Manufacturing, and Quality.

Qualifications

• Bachelor's degree in Engineering or Life Sciences, or equivalent experience.
• 5–8 years in validation within pharma/biotech/medical devices.
• Extensive knowledge of cGMP, FDA, EMA regulations.
• Experience validating Process Automation Systems and PLCs.
• Strong writing and communication skills.

Responsibilities

• Oversee and perform commissioning and qualification of equipment, utilities, and automation systems.
• Apply risk-based validation testing and decision making.
• Create and approve validation masters, protocols, reports, deviations, and change controls.
• Develop and review DQ/IQ/OQ/PQ for new or modified equipment and processes.
• Peer review protocols and reports; track schedules and escalate delays.
• Provide technical leadership across Engineering, MSAT, Manufacturing, Quality.

Skills

Technical writing

Verbal communication

Interpersonal skills

Problem-solving

Leadership

Education

Bachelor's degree in Engineering / Life Sciences

Tools

DCS

MCS

PLC

BAS

Job description

Location: Vacaville, California This is a fully site‑based role. Working together in person supports close, real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.

What you will get:

The full-time base annual salary for this position is expected to range between $93,000 to $155,000.

• 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

The Senior Validation Engineer - CSV at Lonza will be responsible for leading and executing validation activities for manufacturing processes, equipment, computerized systems, and automation control systems to ensure compliance with regulatory requirements and internal quality standards. This role requires a strong understanding of cGMP principles and a proven track record in a pharmaceutical or biotechnology manufacturing environment.

What you will do:

• Responsible for oversight and performance of Commissioning and Qualification of computerized equipment, utility systems, facilities, automation control systems, and site computerized systems.
• Leverage risk management principles to drive risk‑based validation testing and decision‑making.
• Author, review and approve validation master plans, project plans, validation protocols, validation reports, deviations, and change controls in accordance with Lonza's quality management system.
• Develop, execute, and review validation protocols (DQ, IQ, OQ, PQ) for new and modified equipment, processes, and systems.
• Peer review/approve validation protocols, and summary reports generated by junior and contract personnel; monitor and track validation schedules and progress, escalating any potential delays or issues to management.
• Provide technical leadership by representing Engineering Validation on project teams and coordinate activities of Engineering, MSAT, Manufacturing, Quality, and other Vacaville groups required to manage projects.
• Support internal and external audits by providing documentation and technical explanations of validation activities.

What we are looking for:

• Bachelor's degree in Engineering (Computer Science, Information Technology), Life Sciences, a related field or significant related work experience.
• Minimum of 5-8 years of experience in validation within the pharmaceutical, biotechnology, or medical device industry.
• Extensive knowledge of cGMP, FDA, EMA, and other relevant regulatory requirements for validation activities.
• Proven experience with validation of the Process Automation Systems, Distributed Control System (DCS), Manufacturing Control System (MCS), Programmable Logic Controllers (PLC), Building Automation System (BAS) and manufacturing equipment/systems is required.
• Experience with server administration, NetApp storage technologies, and core network infrastructure fundamentals will be a plus.
• Direct validation experience and/or GMP operations experience with increasing levels of responsibility for a wide range of validation projects including validation of large‑scale biochemical manufacturing equipment, facilities, utility, automation and computerized systems.
• Strong technical writing, verbal communication, interpersonal and problem‑solving skills; ability to work independently and as part of a team, organize and manage individuals as well as lead larger scale projects.

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.