Validation Project Manager

RESPONSIBILTIES

  • Developing Validation best practices, standards and guidelines which includes exploring new techniques, methods and other industry practices.
  • Develop validation plans, timelines and cost breakdowns based on project milestones.
  • 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 team members
  • 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)ESSENTIAL EXPERIENCE
  • Validation experience to Industry standards
  • Problem Solving and Analyzing
  • Project Managing (includes AFE process)
  • Fiscal Managing (includes budget preparation)
  • Personnel Staffing and leading a team
  • Goal Setting
  • Strong Communication
  • Improvement of Processes and Process Control

QUALIFICATIONS 

  • B.S. or B.A. in Physical Science, Engineering, or other related discipline
  • 10 years quality engineering experience especially in Validation sector, including previous supervisory experience
  • Knowledge of applicable foreign and domestic regulations
  • Knowledge of process validation techniques
  • Knowledge of quality engineering tools and statistical quality control techniques
  • Knowledge of project management skills
  • Knowledge of quality auditing techniques
  • Basic knowledge of sterilization

Your Recruitment Consultant is Sean Winstanley

Sean Winstanley
Sean joined Arcon Recruitment in early 2018 as our Specialist Technical Recruiter. Originally from the UK, now settled in Ballaghadrereen, Sean brings a wealth of recruitment experience in the IT / Technical arena. Sean has developed excellent skills account managing international, high profile clients solving their recruitment dilemmas.