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Overview
Our client is a leading global pharmaceutical company with a state-of-the-art manufacturing facility in Ireland. They are a key player in the development and production of complex biological products, committed to the highest standards of quality and compliance. This is a prime opportunity to join a dynamic team in a world-class GMP environment.
Responsibilities
Author, review, and execute a wide range of Validation Plans, Protocols, and Reports (IQ, OQ, PQ) for equipment, processes, and cleaning.
Represent the Validation function during internal and external regulatory audits, including those from the HPRA and FDA.
Develop key project documentation, including User Requirement Specifications (URS) and Standard Operating Procedures (SOPs).
Provide hands-on support for validation activities, including Factory and Site Acceptance Testing (FAT/SAT).
Lead and execute Process Validation activities, including Aseptic Process Validation (APS) and Cleaning Validation.
Collaborate cross-functionally with Operations, Quality, and Maintenance departments to deliver on site project goals.
Conduct risk assessments and manage the closure of Corrective and Preventive Actions (CAPAs).
Experience
The ideal candidate will be a detail-oriented and proactive validation professional with a strong foundation in GMP and pharmaceutical validation principles.
A Degree in Science or Engineering.
Minimum of 2 years of hands-on experience in a validation role within the pharmaceutical sector.
Proven experience writing and executing validation protocols and reports.
Direct experience within an aseptic manufacturing environment.
Familiarity with cGMP, Annex 1, and relevant industry guidelines.
Excellent technical writing and analytical skills.
A strong team player with excellent interpersonal and communication skills.
Direct experience representing a company during internal or external audits (e.g., FDA, HPRA).
Specific knowledge of Temperature Mapping for steam sterilisation (Autoclaves) and HTM 01.
Familiarity with ISO-14644 (Cleanrooms) and equipment software validation.
To apply
To apply for this exciting contract opportunity, please submit your CV or contact Lewis Murray at +353 87 204 3307 for a confidential discussion.
Seniority level
Entry level
Employment type
Contract
Job function
Industries: Pharmaceutical Manufacturing
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