Validation Engineer Location: Dundalk Hours: 37.5 hours per week Salary: Competitive Business Unit: Pharma Services Open To: Internal & External Applicants Ref No.: HRJOB10615 ? 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. ? 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. ? Further Information The working pattern for this role is a flex pattern between the hours of 07:00 19:00 with core hours of 10:00 16:00. The role will require occasional travel to other Almac Pharma Services business sites, equipment vendor sites or client sites. ? Apply Now Apply online and tailor your CV to outline how you meet the role criteria. Please upload your CV in PDF format where possible. ? Closing Date We will no longer be accepting applications after 5pm on 15 May 2025. ? RECRUITMENT AGENCIES PLEASE NOTE: Almac will only accept applications from agencies/business partners that have been invited to work on this role by our Talent Acquisition team. Speculative candidate CVs received or submitted directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation. Skills: Quality Experience GMP Experience equipment validation Benefits: Flexible Schedules Attractive Compensation Package Work/Life Balance Employee Referral Bonus Free onsite parking