VALIDATION ENGINEER

Location: Dundalk
Hours: 37.5 hours per week
Salary: Competitive
Business Unit: Pharma Services
Open To: Internal & External Applicants
Ref No.: HRJOB10615
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KEY REQUIREMENTS

• Have eligibility to work in IE OR possess a valid work permit that will allow you to take up full time employment in IE
• Level 5 qualification (or equivalent) OR Minimum 3 years’ experience working within a cGMP pharmaceutical or biological facility
• Quality focused with knowledge, understanding & experience of cGMP quality systems. (e.g. GMP, ISO)
• Experience working with cross functional project delivery teams
• Previous experience working within a Quality, Validation, Manufacturing or Packing related role.
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THE ROLE

The Validation Engineer role sits within the Technical Quality team at Almac Pharma Services and is centred around ensuring compliance with Good Manufacturing Practices (GMP) and Almac’s global quality standards.
The post holder will be responsible for a variety of validation activities to ensure that critical facilities, systems, processes, and procedures meet global regulatory requirements, including those set by the EU and FDA. This involves being a local validation subject matter expert, supporting ongoing projects and initiatives, and occasionally traveling to other business sites, equipment vendor sites, or client sites.
Key responsibilities include participating in all stages of the validation life cycle, from project design documentation to the execution of validation activities and analysis of process validation data. The role also involves assessing systems against regulatory standards, proposing remediation actions, and liaising with various stakeholders.
Additionally, the post holder will support validation lifecycle management, ensure appropriate system access for users, lead validation efforts for new product introductions, and represent the company in client interactions. Other duties include managing project tasks, supporting routine meetings and audits, assisting in operational testing, reviewing documentation, and contributing to continuous improvement projects.
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