Senior Staff Product Validation Engineer

at  Thermo Fisher Scientific

JOB DESCRIPTION

Join us as we expand our business and quality department, which is passionate about revolutionizing the way things are done in our industry! We are seeking a highly skilled and experienced Senior Product Validation Engineer to join our team. The successful candidate will play a meaningful role in ensuring our products’ quality, reliability, and compliance through meticulous validation and testing processes. This is an excellent opportunity for a professional with a strong background in product validation, particularly within the bioprocessing or biopharma industry. Join us in creating exceptional and functional experiences.

What will you do?

• Develop and implement comprehensive validation plans, protocols, and reports for Bioprocess systems.
• Lead product validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Coordinate and carry out validation testing according to regulatory requirements and industry standards.
• Perform risk assessments and develop mitigation strategies to address potential product validation issues.
• Analyze validation data to identify trends, discrepancies, and areas for improvement.
• Prepare detailed validation reports and present findings to multi-functional teams and management.
• Collaborate with R&D, manufacturing, quality, and other departments to ensure seamless integration of validation activities.
• Manage and maintain accurate and organized validation documentation and records.
• Ensure all validation activities are detailed in compliance with regulatory and company requirements.

How will you get here?

EDUCATION:

• Bachelor of Science degree in Engineering or Science field and 3+ years of validation experience in the Bioprocessing industry or equivalent validation cGMP experience.

Experience:

• Minimum of 3 years of product or process validation, Manufacturing or Quality Engineering or equivalent role.
• Strong understanding of validation principles, methodologies, and regulatory requirements.
• Strong background in completing validation protocols for complex systems.
• Extensive experience in solving coordinated systems and resolving technical issues independently.
• Advanced knowledge of Bioprocessing equipment architecture, network infrastructure, and process control solutions such as DeltaV DSC or PLCs is a plus.
• Proficiency in data analysis and statistical tools.
• Familiarity with bioprocessing equipment and systems.
• Detailed, with a focus on maintaining high standards of quality and compliance.
• Certification in relevant areas (e.g., Lean, Six Sigma, Project Management) is a plus.

Knowledge, Skills, Abilities:

• Proven ability to effectively communicate with customers and internal partners to achieve a great outcome for everyone.
• Understand electrical and mechanical assembly drawings is a must.
• Attention to detail for documentation completion.
• Familiarity with Agile PLM, ERP Systems, JIRA, Trackwise Systems.
• Familiarity with Emerson DeltaV Automation and Control Platform or similar advanced process control systems is a plus.
• Must be able to multitask and respond to shifting priorities.
• Must be dedicated to achieving desired outcomes.
• Must have prior mechanical and process equipment experience.
• Technical or Engineering background with strong analytical and interpersonal skills.
• Able to travel occasionally (<15%) domestic or international

PHYSICAL ABILITIES:

• Ability to lift and carry items weighing 35 lbs.
• Ability to work in office and manufacturing environments.
• Ability to get down on the floor or/and climb ladders.
• Ability to effectively use computer-based software, such as Microsoft Office suites, and hardware on laptops, tablets, and mobile devices.

• Develop and implement comprehensive validation plans, protocols, and reports for Bioprocess systems.
• Lead product validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Coordinate and carry out validation testing according to regulatory requirements and industry standards.
• Perform risk assessments and develop mitigation strategies to address potential product validation issues.
• Analyze validation data to identify trends, discrepancies, and areas for improvement.
• Prepare detailed validation reports and present findings to multi-functional teams and management.
• Collaborate with R&D, manufacturing, quality, and other departments to ensure seamless integration of validation activities.
• Manage and maintain accurate and organized validation documentation and records.
• Ensure all validation activities are detailed in compliance with regulatory and company requirements