Website Asset Recruitment

Asset Recruitment

Validation Engineer

**Maternity Cover**
This is an opportunity to join our client’s dynamic team, the role is a permanent position located in Co. Galway. It is an important role in our clients QA department, reporting directly to the Head of Quality, the Validation Engineer responsibilities will involve reviewing and issuing of validation protocols and reports and also the co-ordination of the execution of validation activities (cleaning, process and equipment and computer qualifications) with the relevant departments.

Responsibilities

• Participate in the preparation and review of the Validation Master Plan – Process and Cleaning
• Manage the validation requirements of the company and third party suppliers and CMO’s
• Maintaining and taking responsibility for the cleaning validation strategy.
• Manage the preparation, review and issuing of Validation Protocols and Reports (this to include equipment, cleaning, process and computer system validation)
• To assume responsibility for the cleaning validation master plan confirming to accepted practices and demands of the competent authorities in the EU Implementation of Process Validation of new products for regulatory submissions ensuring compliance to proposed registered specifications
• Establishing, directing and implementing validation and revalidation activities
• Coordination of the execution of Validation according with protocols by Production, Quality Control and R&D teams
• Liaise with contract manufacture customers in seeking their approval for protocols and reports where appropriate
• Reviewing and managing Change Control Forms and Non-Conformances for Validation implications
• Carry out Internal Audits as required
• Responsible for the execution of Risk Assessments or Investigation reports relative to the role
• Collaborate in identifying training requirements in support of validation
• Assisting in the preparation and hosting of associated regulatory and customer audits

Requirements
• B.Sc. / M.Sc. in Scientific Discipline
• 2 years +’ relative experience in a similar position
• HPRA / USFDA Experience
• Demonstrated ability to work and communicate effectively cross-functionally with at all levels of management
• Proactive, motivated, analytical and strategic thinker.
• This position in onsite 5 days a week

Desirable Skills
• Good computer skills with Word, Excel and any other statistical programs
• Knowledge of Process and Cleaning Validation
• Ability to conduct internal audits and perform in external audits

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