**Job Overview**
We are seeking a skilled professional to fill the role of Certification Validation Specialist. The ideal candidate will have experience in ensuring the ongoing validation compliance of computerised equipment and systems in sterile products manufacturing.
Key Responsibilities:
* Design, implement, and execute validation studies for manufacturing and control equipment.
* Provide technical assistance on current US FDA and EU validation requirements for lyophilization, aseptic processing, and sterilisation.
* Evaluate and ensure that the validation status of equipment and systems are in compliance with cGMP at all times.
Required Qualifications:
* Degree in Science (Chemistry, Micro., or Pharmacy preferred) or Engineering (Chemical/Mech/Elec).
* Post-graduate studies as appropriate to augment primary Degree.
* 3-5 years experience working in a Healthcare manufacturing environment ideally part of which would be in the pharmaceutical sector.
* 2-3 years experience in validation environment.
* Project management experience.
Desirable Skills:
* Troubleshooting validation issues associated with projects, process development etc.
* Competent technical knowledge of pharmaceutical plants.
* Knowledge of requirements for GAMP, ISPE Baseline guides.
* Full understanding of relevant quality and compliance regulations.
* Able to execute projects to plan.
* Good knowledge of quality management systems.
* Effective facilitator.
* Good communication skills at organisation, team, and individual levels.
* Understands KPIs for the site.
What We Offer:
A competitive remuneration package, opportunities for career growth, and a dynamic work environment.