Lead Validation Eng

The Lead Validation Engineer will create, review and/or execute primary qualification and validation activities for equipment, instrumentation, utilities, and manufacturing processes. The overall objective of the position is to ensure product quality and site compliance to regulatory requirements.

Requirements

• Bachelor's degree in a science/engineering related field is preferable with related technical background
• Minimum of 10 years' experience in review/approving validation in a pharmaceutical manufacturing environment
• Proven personnel and project management history
• Complete knowledge of pharmaceutical regulations including current GxP, GAMP5, Part 11 and Data Integrity requirements
• Knowledge of ICH Q7, Q9, and Q11 preferred
• Excellent written and oral communication and leadership skills
• Ability to lead and influence people
• Ability to work in and promote a team environment
• Basic understanding of Six Sigma and/or Lean manufacturing tools
• Complete understanding and application of principles, concepts, practices, and standards within discipline
• Understanding of basic statistical principles, expert knowledge of validation principles, techniques, and regulatory expectations
• Knowledge of US and International pharmaceutical manufacturing regulations
• Experience using thermometric studies instrumentation (Kaye Validator/ValProbes/Ellab)

Benefits

• Comprehensive health insurance
• Retirement plan
• Paid time off
• Life insurance