Validation Engineering Specialist II
2 days ago
We are seeking a highly skilled Validation Engineering Specialist II to join our team at Thermo Fisher Scientific. As a key member of our operations team, you will play a critical role in ensuring the quality and integrity of our products and processes.
Key Responsibilities- Design and Implement Validation Strategies: Develop and execute validation plans for process, packaging, and cleaning validation to ensure compliance with regulatory requirements and company standards.
- Prepare and Review Validation Protocols and Reports: Create and review validation protocols and reports for process, packaging, bulk hold studies, shipping studies, cleaning validation, and other additional studies to ensure accuracy and completeness.
- Monitor and Coordinate Manufacturing Execution: Collaborate with manufacturing teams to ensure smooth execution of validation protocols and identify areas for improvement.
- Perform Data Collection and Statistical Analysis: Collect and analyze data to support validation activities and prepare summary reports to communicate findings.
- Lead Annual Monitoring Programs: Develop and implement annual monitoring programs for cleaning and manage site cleaning matrix to ensure compliance with regulatory requirements.
- Monitor and Coordinate Swab Sampling Activities: Coordinate swab sampling activities for cleaning validation to ensure accurate and reliable results.
- Perform Risk Assessments: Conduct risk assessments for equipment, cleaning procedures, and manufacturing processes to identify potential risks and develop mitigation strategies.
- Prepare Risk Assessments, Protocols, and Reports: Prepare risk assessments, protocols, and reports for Continued Process Verification program to ensure compliance with regulatory requirements.
- Conduct Technical Discussions: Engage in technical discussions with clients, project managers, and other stakeholders to drive validation activities and ensure alignment with company goals.
- Maintain a Safe Working Environment: Identify and report potential hazards to ensure a safe working environment.
- Education: Bachelor's or Master's degree in chemistry, pharmacy, engineering, biotechnology, or a related field.
- Experience: Minimum 3 years of experience in validation, process engineering, or quality within the pharmaceutical or biotechnology industry.
- Skills and Abilities: Strong written and oral communication skills, detail-oriented, organized, and able to work in a fast-paced environment. Proficiency in Microsoft Office programs and data analysis software.
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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Validation Engineering Specialist II
3 days ago
Mississauga, Ontario, Canada ThermoFisher Scientific Full timeJob SummaryWe are seeking a highly skilled Validation Engineering Specialist II to join our team at Thermo Fisher Scientific. As a key member of our operations team, you will be responsible for providing specialized validation knowledge and information to support our operations and clients.Key ResponsibilitiesDesign and Implement Validation Strategies:...
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Validation Engineering Specialist II
3 days ago
Mississauga, Ontario, Canada ThermoFisher Scientific Full timeJob SummaryWe are seeking a highly skilled Validation Engineering Specialist II to join our team at Thermo Fisher Scientific. As a key member of our operations team, you will be responsible for providing specialized validation knowledge and information to support our operations and clients.Key ResponsibilitiesDesign and Implement Validation Strategies:...
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Validation Engineering Specialist II
2 days ago
Mississauga, Ontario, Canada ThermoFisher Scientific Full timeJob SummaryWe are seeking a highly skilled Validation Engineering Specialist II to join our team at Thermo Fisher Scientific. As a key member of our operations team, you will be responsible for providing specialized validation knowledge and information to support our operations and clients.Key ResponsibilitiesDesign and Implement Validation Strategies:...
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