Qualification & Validation Engineer

Tandem Project Management View all jobs

  • Waterford
  • Contract
  • Full-time
  • 16 days ago
  • Apply easily
Summary:Our client, a biopharmaceutical company in Waterford is looking for an experienced Qualification & Validation Engineer. The successful candidate will be responsible for leading and executing Process Performance Qualification (PPQ) activities in accordance with the company's global quality standards and applicable regulatory requirements. The role supports the successful delivery of process validation lifecycle activities (Stage 1, Stage 2, and Stage 3) for commercial manufacturing, ensuring that processes consistently produce product meeting predetermined specifications and quality attributes. The role works cross-functionally with MSAT, Operations, Quality Control, and Quality Assurance to ensure PPQ readiness, execution, and reporting are delivered to the highest standards, in full compliance with cGMP, FDA, EMA, and ICH guidelines.Responsibilities:
  • Author, review, and execute PPQ protocols and reports in alignment with the Company's global standards and regulatory expectations.
  • Define PPQ strategy including batch numbers, sampling plans, acceptance criteria, and statistical approaches.
  • Contribute to the development and maintenance of the Process Validation Master Plan (PVMP).
  • Support lifecycle management changes requiring PPQ, including technology transfers and post-approval changes.
  • Develop / Participate in risk assessments to evaluate process risks and define appropriate control strategies.
  • Apply risk-based approaches to PPQ study design, sampling strategies, and acceptance criteria justification.
  • Ensure timely closure of PPQ-related deviations and CAPAs prior to and following PPQ execution.
  • Maintain accurate and audit-ready documentation throughout the validation lifecycle.
  • Work closely with MSAT, Manufacturing Operations, Quality Control, and Quality Assurance to ensure alignment on PPQ strategy, execution, and outcomes.
  • Ensure all PPQ activities are conducted in compliance with applicable regulations and guidelines.
  • Support regulatory inspections and internal audits by providing PPQ documentation and technical expertise.
  • Provide training and technical guidance to operations personnel, validation associates, and cross-functional team members involved in PPQ activities.
  • Design and execute Continued Process Verification (CPV) programs.
Qualifications & Experience:
  • Degree in science (e.g. Chemistry, Microbiology or IT preferred) or Engineering (Chemical/Mech/Elec) discipline.
  • Minimum 3-5 years of experience in pharmaceutical manufacturing, process validation, or quality assurance in a regulated GMP environment.
  • Demonstrated hands-on experience in Process Performance Qualification (PPQ) design, execution, and reporting.
  • Proven track record of authoring and reviewing validation documentation (protocols, reports, deviations, change controls).
  • Strong understanding of process validation principles and lifecycle approach; Understanding of 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 guidelines.
  • Knowledge of statistical methods applied to process validation (e.g., process capability, statistical sampling).
  • Familiarity with qualification of equipment, utilities, and manufacturing systems.
  • Experience with deviation management, CAPA, and change control systems.
  • Excellent project management capabilities with ability to manage multiple priorities.

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