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CSV Engineer
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CSV Engineer - Toulouse, France - 6-Month Contract
I am currently looking for an experienced CSV Engineer who is interested in working for one of the leading companies in the Biopharmaceutical sector. This is a fantastic opportunity to join a hard-working team and work on an exciting project in the biotech sector.
Title: CSV Engineer
Location: Toulouse, France
Positions Available: 1
Type: Contract (6 Months)
If you think your skills and experience are suitable for this position, please do not hesitate to contact me
Responsibilities:
- Possess extensive experience and a deep understanding of all system lifecycle deliverables, ranging from Commissioning & Qualification (C&Q) and Computer System Validation (CSV) documents to System Retirement.
- Serve as a representative of the QA department and acts as a bridge between QA CSV and both internal and external customers.
- Continuously monitor industry regulations and trends, utilize this knowledge to enhance clients' policies and procedures for completing various tasks related to computerized system validation. These tasks include validating process control systems, spreadsheets, and benchtop equipment.
- Offer expert technical guidance to the Validation Manager in making GMP decisions concerning computerized system validation.
- Develops project scopes, implementation plans, and tracking mechanisms. Proactively identify potential roadblocks and solutions to prevent project schedule disruptions
- Ensure that appropriate validation activities are conducted and compliant with regulatory requirements and corporate standards.
- Collaborate with engineering, controls, IT, and other departments, the CSV Specialist evaluates new applications to determine validation requirements.
- Be responsible for implementing continuous improvements to clients' policies, procedures, and local VMPs to ensure efficient operations of the CSV department. Activities that do not positively impact production capacity or compliance are eliminated.
- Serve as the representative or conduit for the Validation Manager, the CSV Specialist addresses CSV issues to identify and resolve GMP concerns.
Requirements:
- Experience working within the pharmaceutical industry under GMP requirements
- 5-10 years of experience working in CSV functions
- Experience as client representative during vendor FAT/SAT execution
- Ability to work in a team and good communication skills
- Fluent in English, French or Dutch skills would be a plus
If you are interested in this role, please do not hesitate to send me your CV today for an immediate response
mbernhard@optimussearch.com
