Global Quality CSV Engineer

Uniphar Group•Gloucester Point, VA

15d•Remote

About The Position

Global Quality CSV Engineer Full Time Permanent Remote The Role To contribute to project workstreams across core functions such as sales, commercial operations, procurement, and planning on a global scale. This position offers a CSV engineer the opportunity to play a pivotal role within a major business transformation programme, engaging with projects that impact the organisation worldwide.

Requirements

Bachelor’s degree (or higher) in Engineering, Computer Science, Life Sciences, or a related field.
Hands-on experience in Computer System Validation within the pharmaceutical or healthcare industry.
Comprehensive understanding of GxP regulations, GAMP 5, FDA 21 CFR Part 11, CSA, and EU Annex 11.
Understanding of data integrity, familiar with MHRA GxP Data Integrity Guidance.
Good level of IT fluency, able to understand complex systems, architecture and connectivity.
Proven experience with validation lifecycle documentation and execution.
Strong knowledge of risk-based validation approaches and change control processes.
Regulatory, customer and commercial focus, able to ensure requirements of all parties are understood and delivered.
Excellent, adaptable, written and verbal communication skills.
Ability to work independently and collaboratively in cross-functional teams.
Strong organisational and time management skills with some project management experience.

Responsibilities

Act as an integral project team member for GxP system projects, responsible for supporting CSV implementation plans for the delivery of new applications across Uniphar globally as directed by line management.
Advise on the development, implementation, and maintenance of Computer System Validation (CSV) strategies and documentation, ensuring adherence to company procedures and regulatory requirements (e.g., GAMP 5, FDA 21 CFR Part 11, EU Annex 11).
Provide pragmatic, expert recommendations for planning and executing validation activities for new and existing computerised systems, including risk assessments, validation planning, protocol development, and reporting.
Facilitate collaboration among Quality Assurance, IT, Project management, test teams and project stakeholders by offering guidance to ensure compliance and timely delivery of validation deliverables.
Support the conduct of periodic reviews and offer expertise in re-validation and change control assessments for validated systems.
Support audits and inspections by regulatory agencies, supplying authoritative validation documentation and responses as needed.
Identify, investigate, and offer solutions for resolving deviations, non-conformances, and CAPAs related to computerised systems.
Maintain up-to-date knowledge of relevant regulations, guidelines, and industry best practices, and share insights to enhance organisational compliance and performance.
Support the delivery of a global CSV plan in collaboration with Business, Technology and Quality teams.
Contribute to the continuous improvement of CSV processes.
Assist in training the business and continually communicate the importance of CSV requirements.
Promote a culture of quality excellence that encourages ethical conduct and commitment to compliance.
This role will involve significant international interaction and some international travel.