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Validation Specialist II
2 months ago
We are seeking a highly skilled Validation Specialist II to join our team at Thermo Fisher Scientific. As a key member of our quality assurance 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
- Develop and execute validation protocols and reports for process, packaging, bulk hold studies, shipping studies, cleaning validation, and other additional studies
- 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
- 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
- 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 and meet tight deadlines in a fast-paced environment
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. Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally.
