CSV Workstream Lead

Wuxi, Jiangsu
Permanent
Full-time

16 days ago

Company DescriptionTurner & Townsend is a global professional services company with over 22,000 people in more than 60 countries.Working with our clients across real estate, infrastructure, energy and natural resources, we transform together delivering outcomes that improve people's lives. Working in partnership makes it possible to deliver the world's most impactful projects and programmes as we turn challenge into opportunity and complexity into success.Our capabilities include programme, project, cost, asset and commercial management, controls and performance, procurement and supply chain, net zero and digital solutions.We are majority-owned by CBRE Group, Inc., the world's largest commercial real estate services and investment firm, with our partners holding a significant minority interest. Turner & Townsend and CBRE work together to provide clients with the premier programme, project and cost management offering in markets around the world.Please visit our website:Job Description

Oversee and perform CSV (Computer System Validation) activities on OT (Operational Technology) systems in line with client's 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 client's 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 client's key stakeholders to ensure their needs are reflected in CSV activities and support lessons learnt for technical work packages.

Qualifications

Bachelor's or Master's 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 InformationOur 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#LI-TW1Join 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.

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