Staff Product Validation Engineer

About the position

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.

Responsibilities

• 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.

Requirements

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

Nice-to-haves

• Certification in relevant areas (e.g., Lean, Six Sigma, Project Management) is a plus.
• Familiarity with Agile PLM, ERP Systems, JIRA, and Trackwise Systems.
• Familiarity with Emerson DeltaV Automation and Control Platform or similar advanced process control systems is a plus.

Benefits

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs.
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement.
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy.
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan.
• Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount.