Qualification & Validation Engineer

Tandem Project Management View all jobs

  • Waterford
  • Contract
  • Full-time
  • 8 days ago
  • Apply easily
Summary:Our client, a biopharmaceutical company in Waterford, is seeking an experienced Qualification & Validation Engineer to join their Quality Assurance team. The successful candidate will be responsible for ensuring that equipment, facilities, utilities, processes, and computer systems used in pharmaceutical manufacturing meet required quality and compliance standards. The role focuses on the design, execution, review, and approval of qualification and validation activities in line with cGMP and regulatory requirements, supporting validation lifecycle activities and ensuring inspection readiness. The position will work cross-functionally with Engineering, Manufacturing, and Quality teams to support compliant and efficient project delivery.Responsibilities:
  • Provide quality oversight of qualification and validation activities within assigned areas
  • Prepare and review qualification and validation documentation, including protocols, reports, risk assessments, and traceability matrices, in line with defined timelines
  • Ensure appropriate documentation and closure of deviations, non-conformances, and CAPAs
  • Evaluate and support change control activities from a validation and compliance perspective
  • Ensure all qualification and validation activities are executed in compliance with regulatory requirements and internal quality standards
  • Participate in internal and external audits and inspections, providing documentation and technical support as required
  • Collaborate with cross-functional teams including Engineering, Manufacturing, and Quality Control to support validation activities
  • Provide subject matter expertise in qualification and validation to project teams
  • Identify opportunities for process improvements and contribute to continuous improvement initiatives
Qualifications & Experience:
  • Degree in a scientific discipline (e.g. Chemistry, Microbiology, IT) or Engineering (Chemical, Mechanical, Electrical)
  • Minimum 5+ years' experience in validation and/or quality assurance within a pharmaceutical or biopharmaceutical environment
  • Strong understanding of process validation principles and lifecycle approach
  • Good knowledge of cGMP regulations including FDA 21 CFR Parts 210/211, EU GMP Annex 15, and relevant ICH guidelines (Q8, Q9, Q10, Q11)
  • Experience with qualification of equipment, utilities, and manufacturing systems
  • Knowledge of data integrity principles (ALCOA+)
  • Experience with deviation management, CAPA, and change control systems
  • Strong experience in preparing and reviewing validation documentation (protocols, reports, SOPs)
  • Ability to perform risk assessments, analyse validation data, and resolve deviations
  • Good organisational and project management skills, with the ability to manage multiple priorities

Tandem Project Management