GerTEK Project Management & Technical Services are an outsourced technical services provider delivering worldwide contract and permanent staffing solutions. We are accepting applications for our Validation Engineer role based in Sligo.
- Coordination / direction and active participation in the validation and qualification of equipment, utilities, processes, and software in compliance with client’s policies, FDA, European cGMP and GAMP standards.
- Develop and execute the qualification for Information Systems and GxP software systems.
- Ensure up-to-date regulatory requirements for all validated operations
- Generation/maintenance/execution of Project Validation Plans and schedules.
- Lead the definition, design, and execution of computer/automation/ enterprise systems validation and verification activities throughout all phases of the SLC Ensure all plant personnel are fully aware of quality requirements (where relevant) by providing the necessary training.
- Generation of validation protocols and final reports to cGMP standards.
- Provide input into project phases from design, commissioning, and qualification.
- QA support for validation investigations and implementation of corrective actions.
- Creation/Review/Approval of various validation and qualification documents
- Management of validation, exception event, and change control processes.
- Performing cross training within the team and training of new team members.
- Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems.
Education & Key Requirements
- 3 years plus experience writing, reviewing and executing validation documentation – Validation Plan, FAT, SAT, IQ, OQ, PQ, RTM.
- 3 years plus of knowledge of cGMP and regulatory requirements relating to the pharmaceutical / medical device industry
- Project planning experience a distinct advantage
- Experience with computer controlled equipment automation systems and Human Machine interphases beneficial
- Strong communication (written and oral), presentation and troubleshooting skill required
- Effective interpersonal and organizational skills.