We are recruiting for an experienced and motivated Validation Specialist to join our team. This is a fantastic opportunity for professionals with a background in validation to further their career. This role will work cross functionally and be instrumental in forging the company’s validation processes.
About You:
- Bachelor’s degree in Science, Engineering, Technology or a related discipline.
- 3 years of hands-on experience working as a validation engineer/specialist in a GMP environment,
- Experience within a similar role – with focus on validation projects
- Knowledge of HVAC/Refrigeration systems including automation. • Excellent communication skills including ability to present technical information to non SME audience. • Committed to deliver outstanding customer service.
- A self-starter who can drive long-term objectives.
- Ability to gather, understand, analyze and interpret information and concepts quickly.
- Experience in end-to-end qualification. Developing URS, IQ/OQ/PQ.
- A third level qualification in a relevant field
- A team player, proactive in approach and solution focused
Responsibilities:
- Generation, execution and close out of validation projects relating to existing products and new product introductions.
- Participate in project teams and assist in determining project schedules and the appropriate levels of validation.
- Execution and documenting risk assessments with respect to validation activities.
- Investigate, track and resolve deviations during qualification activities.
- Proactively supports their direct Supervisor to successfully achieve departmental and site objectives and undertake assigned projects.
- Adopts positive cross functional relations.
- Assess validation requirements (new equipment, change controls, etc.), monitor project status, and ensure timely updates.
- Maintain validation status through monthly reports and meetings, collaborating with project managers to adhere to schedules.
- Ensure GMP compliance, stay updated on validation innovations.
- Generate and execute validation protocols, review project change controls, and prepare necessary documentation and reports.
- Contribute to developing company validation standards and assist with department growth as needed.
- Present professionally to management and auditors, support processes, and address queries during regulatory inspections.
- Liaise with relevant Q.A. personnel to complete project documentation within defined time frames.
