GerTEK Project Management & Technical Services are hiring for an experienced Validation Engineer to join our team.
- Updating of validation procedures, templates and involvement in process improvements for Quality Organisation
- Participate in validation of Laboratory Equipment and Test Method Transfer
- Coordination / direction and active participation in the validation and quality assurance of site equipment, utilities, processes and software in compliance with company policies, FDA, European cGMP and GAMP standards.
- Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems.
- Generation/maintenance/execution of the Site Validation Master Plan.
- Generation/maintenance/execution of Project Validation Plans and schedules.
- Generation of validation protocols and final reports to cGMP standards.
- Generation of validation investigations and implementation of corrective actions.
- Creation/Review/Approval of various quality documents and test data.
- Completing all required training before executing a task.
- Documenting all activities in line with cGMP requirements.
- Performing cross training within the team and training of new team members.
Education & Key skill requirements
- Bachelor’s degree or equivalent in Quality, Engineering, Science or related discipline.
- 2 years plus Validation/Quality experience.
- Strong communication (written and oral), presentation and troubleshooting skills required
- Effective interpersonal and organizational skills.