Lonza
Senior Validation Engineer - CSV (OT)
US - Vacaville, CA · Senior · Full-time
Sponsorship not specified$93k-$155kDetected 27 days ago
Code ReviewPLCControlsGMPFDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationProblem SolvingWriting
About the role
- What you will get: The full-time base annual salary for this position is expected to range between $93,000 to $155,000.
- About Lonza At Lonza, our people are our greatest strength.
Responsibilities
- Leverage risk management principles to drive risk-based validation testing and decision-making.
- Develop, execute, and review validation protocols (DQ, IQ, OQ, PQ) for new and modified equipment, processes, and systems.
- Support internal and external audits by providing documentation and technical explanations of validation activities.
Requirements
- Bachelor's degree in Engineering (Computer Science, Information Technology), Life Sciences, a related field or significant related work experience.
- Extensive knowledge of cGMP, FDA, EMA, and other relevant regulatory requirements for validation activities.
- 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.
Nice to have
- Experience with server administration, NetApp storage technologies, and core network infrastructure fundamentals will be a plus.
Compensation
- The full-time base annual salary for this position is expected to range between $93,000 to $155,000.
Benefits
- Performance-related bonus
- Medical, dental and vision insurance
- Life insurance, as well as short-term and long-term disability insurance
- Minimum of 5-8 years of experience in validation within the pharmaceutical, biotechnology, or medical device industry.
Company info
- What we are looking for:
- 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.
- 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.
- If you're ready to help turn our customers' breakthrough ideas into viable therapies, we look forward to welcoming you on board.
This listing is sourced directly from Lonza's careers page and normalized into a canonical job model.