With a global workforce of ~38,000, this leading pharmaceutical organisation aim to deliver increased access to affordable, quality medicines for patients worldwide. Their global portfolio includes best-in-class, iconic brand name products as well as global key brands; generics, including branded and complex generics; biosimilars; and over-the-counter offerings across a wide range of therapeutic areas. With high-quality global manufacturing, scientific excellence and a vast supply chain network, they are uniquely positioned to improve access to medicine for patients worldwide. Due to changes on site, a requirement has arisen for a CSV Engineer.

This role has a highly flexible hybrid working structure in place.

The Position:

• Support activities include but are not limited to; the preparation of Decommissioning/Validation/Qualification Plans, Risk Assessments, User Requirement Specification, Traceability Matrix, Testing (IQ, OQ/PQ), Data Migration, SOPs and Change control.
• Manage, co-ordinate, develop and execute the validation deliverables for new Information System (IS) and current projects.
• Support and co-ordinate the qualification, decommissioning and validation processes.
• Responsible for ensuring that computerized systems are in full compliance with regulatory requirements, company policies and procedures.
• Provide compliance leadership, direction, and execution in Computer System Validation for new and existing projects
• Support the resolution of project deviations/errors and provide quality guidance on GxP regulatory requirements (including but not limited to 21 CFR Parts 11, 820 and EU GMP Annex 11.) Participate in required project teams.
• Responsible for ensuring that the Technical Development Manager is consulted on all validation deliverables.
• Involvement in both internal audits and external inspections as required

The Person:

• The ideal candidate will be a Science / Engineering graduate with minimum 3 yrs. experience in similar role.
• Knowledge of Cleaning validation would be a distinct advantage.
• A motivated and flexible person who can formulate detailed plans with minimum supervisory influence and manage them through to completion.
• Demonstrated strong communication and team-working skills including the ability to work effectively and influence decisions across functions, communicating effectively through verbal and written means.
• A track record of developing efficient, innovative, and creative solutions to complex and challenging engineering problems, using established tools and frameworks
• A working understanding of appropriate regulatory requirements

To learn more, apply online or contact Pádraig on +353 87 428 0873 or please submit an updated CV.