Collins McNicholas

VALIDATION PROJECT MANAGER

The Validation Project Manager will be responsible for the validation strategy and documentation approval. They will also be responsible for resource assignment and development of the validation team. This role will be a key player in ensuring efficient execution of New Product Development, Change Controls, Design Improvement and Capacity projects.

Responsibilities

  • Developing Validation best practices, standards and guidelines which includes exploring new techniques, methods and other industry practices.
  • Develop validation plans, timelines and cost breakdowns in line with project.
  • Reviews and approves Validation protocols and summary reports generated by the Validation staff against standard operating procedures and policies as well provides guidance to Validation staff writing protocols and final reports.
  • Leads projects by developing appropriate plans, schedules, resource loading and other project deliverables as required
  • Manage a team of validation engineers/technicians and establish individual development targets and handle annual performance reviews with the team
  • Collaborate with Engineering Managers and Engineers to verify and develop validation setup and procedures
  • Coordinate external validation with contract houses as required
  • Provides leadership in change management & in risk assessment, specifically process risk and capability analyses on processes
  • Provides leadership in facilitating internal and external audits and completes internal audits as per audit schedule
  • Ensures training to FDA good manufacturing practices and ISO quality standards (including defect recognition)

The incumbent should be very familiar with Industry standards for validation processes and have good problem-solving and analyzing skills. Leadership and management ability will be key in managing projects and budgets. You will have responsibility for setting goals and developing and leading a team. 

Qualifications 

  • Third level Science or Engineering qualification
  • 10 years quality engineering experience with a strong emphasis on validation
  • Some supervisory experience
  • Knowledge of applicable foreign and domestic regulations
  • Knowledge of process validation techniques
  • Knowledge of quality engineering tools and statistical quality control techniques
  • Project management skills
  • Knowledge of quality auditing techniques
  • Basic knowledge of sterilization

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For a confidential discussion and more information on the role, please contact Davin Ferguson on 0719140251 or email davin.ferguson@collinsmcnicholas.ie

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