Validation Engineering Specialist II

4 weeks ago

Mississauga, Ontario, Canada Thermo Fisher Scientific Full time
Job Title: Validation Engineering Specialist II

Thermo Fisher Scientific is seeking a highly skilled Validation Engineering Specialist II to join our team. As a key member of our validation team, you will be responsible for ensuring the accuracy and reliability of our products and processes.

Key Responsibilities:
  • Design and implement validation strategies for process, packaging, and cleaning validation
  • Prepare and execute validation protocols and reports
  • Monitor and coordinate manufacturing execution and provide training on validation protocols
  • Perform data collection, statistical analysis, and prepare summary reports
  • Lead annual monitoring programs for cleaning and manage site cleaning matrix
  • Monitor and coordinate swab sampling activities for cleaning validation
  • Perform risk assessments for equipment, cleaning procedures, and manufacturing processes
  • Prepare risk assessment, protocols, and reports for Continued Process Verification program
  • Conduct technical discussions with clients, project managers, and other stakeholders to drive validation activities
Requirements:
  • Bachelor's or Master's degree in chemistry, pharmacy, engineering, biotechnology, or a related field
  • Minimum 3 years of experience in validation, process engineering, or quality within the pharmaceutical or biotechnology industry
  • 1 year of experience conducting statistical analysis is an asset
Preferred Qualifications:
  • Equivalent combinations of education, training, and relevant work experience may be considered
  • Strong written and oral communication skills
  • Detail-oriented and organized with a high degree of accuracy and thoroughness
  • Excellent interpersonal skills, communication, and organizational skills
  • Strong judgment, decision-making, and trouble-shooting skills
  • Ability to multi-task, meeting tight deadlines in a fast-paced environment
Working Conditions:

The position requires ordinary ambulatory skills and physical coordination sufficient to move about lab/lab office locations. Ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time. Manipulation (lift, carry, move) of light to medium weights of 10-35 pounds. Arm, hand, and finger dexterity, including ability to grasp and type for prolonged periods of time. Visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time. Ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.

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