Senior Validation Engineer - CSV (OT)

Lonza•Vacaville, CA

7d•$93,000 - $155,000•Onsite

About The Position

The Senior Validation Engineer (Computer System Validation) - Operational Technology, 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.

Requirements

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.
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.

Nice To Haves

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.

Responsibilities

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.