Validation Engineer Contractor
2 weeks ago
Team Horizon is seeking a Validation Engineer for a 12-month contract for our client's manufacturing facility in Sligo.
Why you should apply:
- Exciting opportunity to join a global pharmaceutical company and join a diverse and experienced team.
What you will be doing:
- Ensure all Computerized systems are qualified in compliance with Data Integrity policies and regulatory requirements.
- Co-ordinate, direct, and actively participate in the validation of site equipment, facilities, utilities, processes, and software in compliance with company policies, FDA, European cGMP, and GAMP standards.
- Generation and maintenance of the Validation Master Plans.
- Generation and maintenance of Project Validation Plans.
- Generation of validation plans, protocols, and final reports to cGMP standard.
- Review and approval of all protocols and final reports.
- Management of the validation change control process.
- Adhere to and support all EHS & E standards, procedures, and policies.
What you need to apply:
- 3rd level qualification in a relevant engineering or scientific discipline.
- A minimum of 5-10 years' experience in a cGMP regulated environment.
- A good understanding of regulatory requirements.
- Experience in Process validation (PPQ) in API or Drug product and experience with managing validation events / Non-Conformances during PPQ.
- FUE qualification essential (preferably API). Experience with working in fast-paced projects. Understanding of ASTM E risk-based qualification.
- Good understanding of Critical Process Parameters/ Non-critical process parameters and their relationship with instrument calibration tolerances and selection of PPQ test criteria.
- Ability to work directly with Engineering and other stakeholders to understand validation requirements.
- Ability to react to problems quickly during validation.
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