FREE ACCESS
5,000–10,000 jobs/day
See all jobs on JobTailor
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
About the role
Key responsibilities & impact- Lead the preparation, review, and execution of Validation Plans, Protocols, and Reports for Cleaning, Equipment, Steam Sterilisation, and Process Validation in accordance with cGMP and regulatory requirements.
- Review and assess change controls, evaluate impact to validated systems, and define appropriate validation and re‑qualification requirements.
- Represent the Validation function during internal and external regulatory inspections, including those conducted by HPRA and FDA.
- Generate, review, and approve validation documentation including User Requirement Specifications (URS), protocols, reports, and SOPs.
- Provide hands‑on execution and oversight of validation activities to ensure equipment cleaning and processes meet current GMP and industry standards.
- Maintain the Site Validation Master Plan (VMP) and associated Project VMPs, defining validation approaches, study requirements, requalification strategies, and frequencies.
- Execute and coordinate revalidation activities in line with change management and lifecycle requirements.
- Perform risk assessments, manage deviations, and ensure timely closure of CAPAs.
- Independently resolve complex technical challenges, applying sound scientific judgment and adaptability in a dynamic manufacturing environment.
- Collaborate cross‑functionally with Operations, Quality, Engineering, and Maintenance to lead qualification and validation efforts supporting site projects.
- Review and analyse validation data to verify adequacy, data integrity, and regulatory compliance.
- Perform additional validation‑related activities as assigned by the Manager or Director.
- Act as a delegated signatory for validation documentation, with appropriate qualification and authorization from the Validation Manager.
Requirements
What you’ll need- A degree in Science, Engineering, or a related discipline, or a minimum of 5 years’ experience in a Validation role within the pharmaceutical or regulated manufacturing sector.
- Demonstrated project management experience with the ability to plan, coordinate, and deliver complex validation activities.
- Hands-on experience executing Cleaning Validation, Process Validation, Aseptic Process Validation, and Software Validation for manufacturing systems.
- Proven experience working within a Quality or Validation function in a GMP pharmaceutical environment.
- Excellent technical writing and analytical skills, with experience authoring and reviewing validation documentation.
- Strong working knowledge of cGMPs, regulatory expectations, and industry/federal guidelines.
- Experience representing organizations during corporate audits and regulatory inspections, including FDA and HPRA.
- Working knowledge of HTM 01 (Part C – Steam Sterilisation) and autoclave systems.
- Familiarity with ISO 14644 (Cleanrooms and Associated Environments).
- Strong understanding of EU GMP Annex 1 – Manufacture of Sterile Medicinal Products.
- Experience working in an aseptic manufacturing environment.
- Proficiency in Microsoft Word, Excel, and Access.
- Strong interpersonal and communication skills, enabling effective collaboration across multiple departments.
Benefits
Comp & perks- Highly competitive salary package
- Group pension scheme with contribution options of 1.5%, 3%, 5%, or 7%, with company matching
- Private medical insurance for the employee
- Ongoing career development opportunities within a rapidly expanding organization
- Strong commitment to succession planning and internal promotion
- Education and professional development allowance
- Wellness and social initiatives, including activities such as padel and summer events
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Validation PlansCleaning ValidationProcess ValidationAseptic Process ValidationSoftware ValidationTechnical WritingRisk AssessmentsData IntegrityCAPA ManagementChange Management
Soft Skills
Project ManagementAnalytical SkillsInterpersonal SkillsCommunication SkillsCollaborationProblem SolvingAdaptabilityLeadership