QA Validation II

Job Title
Specialist, Validation II

Job Summary

The Validation specialist is responsible for protocol generation, execution, and management of qualification and validation. This is a hands-on role responsible for daily on-the-floor activities in qualification and validation.

General Responsibilities

• 
  Calibration, qualification, and validation schedule and program control and management
• Calibration, qualification, and validation protocol and repost generation, reviewing, and documentation
• Calibration, qualification, and validation execution and operation
• Manage and provide coordination for all contracted service vendors utilized to perform certification, operation, and controlling
• Provide training on established procedures to staff, maintenance personnel, and contracted vendors as required to perform work in a regulated calibration, qualification and validation
• Develop SOPs for Calibration, qualification, and validation related processes as needed
• Support implementation of cGMP process improvements following the stablished change control process
• Related regulation, guidance and other compliance update and training
• Perform additional duties as needed

• The company reserves the right to add or change duties at any time.

Job Qualifications & Skills

• 
  Education: Bachelor’s degree in Engineering, Chemistry or biological sciences required. Advanced science or engineering degree highly preferred.
• Experience: Minimum of 3 years of validation in Biotech/Life Sciences industry.
• Working knowledge and understanding of GMP, GCP, GDP, and relevant ICH and FDA guidelines, experience within an FDA/EMA regulated environment highly preferred.
• Must be able to work on off shift hours as well as part of the on-call rotation as needed is required, weekend shift likely as activities scale.
• Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.
• Willing to accept temporary responsibilities outside of initial job descriptions.
• Ability to work well in a growing organization cross-functionally; must be able to wear multiple hats, prioritize, meet deadlines, and communicate at all levels of the organization

Benefits & Perks

• Competitive compensation
• Medical, Dental and Vision Insurance
• Business casual work attire
• Fully stocked kitchen and much more!