CSV Workstream Lead
CSV Workstream Lead
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Job Description
- Oversee and perform CSV (Computer System Validation) activities on OT (Operational Technology) systems in line with clients requirements.
- Provide technical governance and support throughout the project lifecycle relating to CSV aspects.
- Champion Operational Lifecycle within specialist areas including pharma industry CSV good practices facilities and utilities process equipment and GAMP approach for OT systems.
- Ensure proper implementation of clients CSV guidance and develop/enhance CSV documentation.
- Lead system functional risk assessment activities and support OT system Risk Impact Determination (RID).
- Develop qualification mitigation strategies for OT systems and produce associated reports.
- Review and comment on technical specifications from vendors/contractors focusing on OT aspects.
- Lead C&Q activities on key systems (e.g. WCS AI-IPC RFID EMS) and provide tactical advice to resolve technical difficulties during execution.
- Engage with clients key stakeholders to ensure their needs are reflected in CSV activities and support lessons learnt for technical work packages.
Qualifications :
- Bachelors or Masters degree in Engineering Life Sciences or related field
- Extensive experience in CSV activities within pharmaceutical or regulated industries
- In-depth knowledge of CSV methodologies regulatory guidelines and computer systems
- Proficiency in developing and reviewing validation documentation
- Strong understanding of software development lifecycle and risk management
- Demonstrated ability to lead validation teams and provide technical governance
- Excellent communication skills for stakeholder engagement and project management
- Experience in translating business needs into validation requirements
- Commitment to supporting lessons learned and offering technical best-practice advice
Additional Information :
Our inspired people share our vision and mission. We provide a great place to work where each person has the opportunity and voice to affect change.
We want our people to succeed both in work and life. To support this we promote a healthy productive and flexible working environment that respects work-life balance.
Turner & Townsend is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees and actively encourage applications from all sectors of the community.
Please find out more about us at our social media conversations for more information about Turner & Townsend and our exciting future projects:
It is strictly against Turner & Townsend policy for candidates to pay any fee in relation to our recruitment process. No recruitment agency working with Turner & Townsend will ask candidates to pay a fee at any time.
Any unsolicited resumes/CVs submitted through our website or to Turner & Townsend personal e-mail accounts are considered property of Turner & Townsend and are not subject to payment of agency fees. In order to be an authorised Recruitment Agency/Search Firm for Turner & Townsend there must be a formal written agreement in place and the agency must be invited by the Recruitment Team to submit candidates for review.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
