Our organization is seeking a talented Validation Specialist to join our team.
This is a high-impact role requiring immediate engagement in qualification activities and close collaboration with Commissioning & Qualification (C&Q) and Automation teams.
Responsibilities:
* Lead and execute the full lifecycle of qualification activities for both process control and packaging serialization systems.
* Develop and manage validation deliverables including URS, FS, DS, Risk Assessments, IQ/OQ/PQ protocols, and final reports.
* Ensure that validation activities comply with site procedures, GMP regulations, and industry best practices (GAMP 5, FDA 21 CFR Part 11).
* Provide subject matter expertise for equipment and automation-related validation issues, including deviation resolution and change control.
* Participate in FAT, SAT, commissioning, and system handover processes for Delta V and serialization systems.
* Engage directly with project teams to ensure validation requirements are integrated into project planning and execution.
* Collaborate with cross-functional teams including QA, Engineering, Automation, and Capital Projects to align validation strategies.
* Support data integrity assessments and implement improvements where necessary.
Requirements:
* Experience in equipment/system qualification or CSV roles in a GMP environment.
* Previous exposure to Serialization systems in packaging environments is highly desirable.
* Demonstrated ability to work independently and deliver in fast-paced, project-driven environments.
* Experience in authoring and executing qualification documents (URS, FS, DS, IQ, OQ, PQ).
* Excellent communication and stakeholder management skills.
* Ability to work on-site at least once per week; remote working offered during documentation phases.