Validation Engineering Specialist II

at  Thermo Fisher Scientific

EDUCATION:

Bachelors/Master’s in chemistry, Pharmacy, Engineering, Biotechnology or related field.

EXPERIENCE:

Minimum 3-year experience in validation, process engineering or quality within the pharmaceutical/ biotechnology industry.
1 year experience conducting statistical analysis is an asset

KNOWLEDGE, SKILLS AND ABILITIES:

Strong written and oral 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. Mini-Tab and data analysis knowledge an asset. Demonstrated computer proficiency with Microsoft Office programs. Proficiency with the English Language.

PHYSICAL REQUIREMENTS:

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

• Design validation strategies for process, packaging, or cleaning validation
• Prepare 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 trainings 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.
• Maintain a safe working environment and report potential hazards.
• Flexible to work extended hours or off-shifts based on project expectations (as required)