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Validation Specialist
1 week ago
Cpl Healthcare is currently seeking a highly skilled Validation Engineer to join our team. As a key member of our operations team, the successful candidate will be responsible for ensuring that all aspects of our validation processes are carried out in accordance with regulatory requirements and company standards.
The ideal candidate will have a minimum of 3 years' experience in a pharmaceutical environment, with a strong understanding of GMP and GLP principles. They will also possess excellent communication and organizational skills, with the ability to work effectively in a fast-paced environment.
The successful applicant will be responsible for the compilation and execution of validation protocols, as well as the collection, testing, measurement, and data analysis of samples. They will also be required to review validation documentation and participate in calibration activities on-site.
Key Responsibilities
- Compilation and execution of validation protocols
- Collection, test, measurement, data entry, data analysis of samples
- Software validation
- Statistical analysis (in particular data interpretation, sample sizes)
- Validation documentation review
- Calibration activities on-site
Requirements
- Minimum 3 years industrial experience in a facility manufacturing in pharmaceutical environment, vitro diagnostic products or equivalent
- Educated to BSc level in science or engineering related discipline or equivalent
- Knowledge of elements of validation documents (VMP / FAT / SAT / IQ / OQ / PQ etc.)
- Understanding of production operations, GMP and GLP requirements
- Strong organisational skills from both administrative and hands-on standpoints
- Ability to demonstrate a high level of care and attention to all aspects of the role and show a desire to achieve excellence through own initiative
- Proven team player capable of working within multiple areas while maximising performance
Desirable Skills
- Familiarity in the use of the following equipment, instrumentation and software: Incubators, Fridges, Freezers, Cold Rooms
- Filling, Stoppering, Capping, Labelling, Packing manufacturing lines (fully automated, semi-automatic or manual) Freeze Drying processing equipment
- Validation of Computerized Systems (FDA regulation) Microsoft Office (Word, Excel, PowerPoint etc.)
- Statistical Software
