CSV Engineer
London / United Kingdom / Full Time
About CAI
CAI is a 100% employee-owned company established in 1996, that has grown year over year to nearly 900 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.
Meeting a Higher Standard
Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.
As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:
• We act with integrity
• We serve each other
• We serve society
• We work for our future
With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude. That is how we have grown exponentially.
CAI agents will be exposed to cutting edge technologies in the advanced medicine space. You will have an opportunity to work with recognized subject matter experts allowing YOU to be a key player in bringing lifesaving therapies to market. As part of our company culture, we invest in YOUR future, and commit to hands on certifications as well as professional training. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.
Requirements include:
We are now seeking CSV Engineers to join our growing operations in the UK. The role of a CSV Engineer in CAI is to:
• Prepares/reviews validation documentation related to projects/change controls.
• Manages change controls and other compliance related tasks e.g., non-conformances.
• Participates in the review of current and future CSV procedures and polices
• Analyses the results of testing and determines the acceptability of results against predetermined criteria.
• Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
• Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.
• Coordinates with other departments or outside contractors/vendors to complete validation tasks.
• Participates in regulatory audits and communicates company’s computer validation policies.
• Assesses company’s computer systems and identifies any potential Part 11 or Annex 11 gaps.
• Manages projects and prepares status reports using Microsoft project and other communication tools.
• May supervise, lead, or manage lower-level personnel.
Position Requirements:
• Requires BS/BA in Engineering, Chemistry, or Life Sciences with 5+ years of related experience within the fields of Automation and Computer systems and IT Infrastructure Qualification/validation; will substitute relevant experience for education.
• Experience in a GMP environment essential.
• Excellent oral and written communication skills
• Excellent problem-solving skills
• Customer-service focused.
• Able to travel domestically and internationally if required.
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