We are recruiting a QA Qualification and Validation Engineer to work on contract at our Global Biopharma client's site in Waterford.Qualifications & Validation Engineer – Quality Assurance (QA)Responsibilities:Quality oversight of qualification and validation tasks in his/her areaPreparing and reviewing qualification and validation documentation, including protocols, reports, risk assessments, and traceability matrices according to pre‑defined timelinesEnsuring proper documentation of deviations, non‑conformances, and corrective actionsEnsuring proper evaluation (validation expertise) of change controlsEnsuring all qualification and validation activities comply with regulatory requirements (e.g., FDA, EMA) and company quality standardsParticipating in internal and external audits and inspections, providing necessary documentation and supportCooperating with cross‑functional teams, including engineering, manufacturing, and quality control, to ensure smooth execution of validation activitiesProviding qualification and validation expertise when requestedIdentifying opportunities for improving qualification and validation processes and contributing to continuous improvement initiativesAbout you:Degree in science (e.g., Chemistry, Microbiology or IT preferred) or Engineering (Chemical/Mechanical/Electrical) disciplineMinimum 5 years of experience in Validation and/or QA within the pharmaceutical/biotech industryNatural influencer and works well as part of a multifunctional teamHighly motivated and self‑resilientAdaptable and flexible as well as a pragmatically minded problem solverTechnical skills:Strong understanding of process validation principles and lifecycle approach; understanding of cGMP regulations: FDA 21 CFR Parts 210/211, EU GMP Annex 15, FDA Process Validation Guidance (2011) and EMA process validation requirements, working knowledge of ICH Q8, Q9, Q10, Q11 guidelinesFamiliarity with qualification of equipment, utilities, and manufacturing systemsStrong knowledge of data integrity principles (ALCOA)Experience with deviation management, CAPA, and change control systemsProficiency in preparing and reviewing qualification and validation documentation, including protocols, reports, and standard operating procedures (SOPs)Excellent project management capabilities with ability to manage multiple prioritiesExpertise in conducting risk assessments, analyzing validation data, and resolving deviations and non‑conformancesExcellent communication skills to effectively collaborate with cross‑functional teamsStrategic thinking with focus on balancing compliance requirements with business needs
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