Validation Engineer 2

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Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. 

Your Role:

The Validation Engineer II is an intermediate-level role responsible for the validation and qualification of equipment, materials, processes, and tests used in the production of high-purity filters, with a strong emphasis on safety and quality. This position is responsible for executing Quality System elements such as CAPAs, Change Controls, Deviations, and Investigations related to equipment, utilities, and raw material qualifications. The Validation Engineer II will design and lead intermediate to complex validation activities, including authoring, reviewing, and executing protocols and reports. This role also leads investigations into validation discrepancies to determine root causes and supports change requests within the Change Management system, ensuring proposed solutions align with operational needs and quality standards. Working collaboratively with senior engineers and cross-functional teams, the Validation Engineer II helps establish qualification techniques, assess risk, resolve issues, and ensure validation activities are compliant and effective.

Duties Include:

• Perform Qualification and Validation of Manufacturing Equipment, QC equipment, raw materials, and Supply chain equipment including FAT, SAT, Installation and Operational Qualifications, and Performance qualifications (temperature mapping and process qualification).
• Perform Validation program tasks to ensure GMP Manufacturing Equipment, Facilities, Utilities, Computer Systems, and Process remain in a validated and controlled state in accordance with original validation criteria to maintain product supply.
• Perform manufacturing equipment design qualification and risk assessment to ensure that the equipment design meets manufacturer's specification and functional requirements.
• Coordinate the scheduling of validation execution by collaborating with Manufacturing, Planning and Quality Control departments and analyze the test results against pre-determined acceptance criteria.
• Collaborates with Manufacturing, Engineering, Process Support, Supply Chain, Quality and R&D to ensure a specific product meets current regulation and quality standards.
• Prepare, maintain, and review Validation documentation such as CQV documentation for DQ, FAT, IQ, OQ, PQ, and process qualification.
• Perform assessment of vendor change notifications to identify the impact of the change on validated status of equipment and GMP production. Review equipment calibration specifications and any out of tolerance records to determine the extent of failure on the validation test.
• Support Validation department during internal and external audits.
• Consults with management, assesses customer requirements, and studies product characteristics to select validation objectives and standards.

Who You Are

Minimum Qualifications:

• Bachelors Degree in Biology, Computer Science, Chemical Engineering, Business Management, or other Life Science, Technology, Engineering, or Mathematics discipline. 
• 2+ years of experience in an FDA regulated medical device manufacturing facility, pharmaceutical facility or other regulated industry supporting the validation of automated and manual assembly processes with working knowledge of ISO, cGMPs and Good Engineering Practices.

Preferred Qualifications:

• Manage and lead multiple projects and participate on cross-functional project teams.
• Self-driven, able to work independently, and in teams with urgency.
• Strong communication skills.
• Proven ability to analyze intermediate level data sets, apply statistical analysis principles, and clearly summarize conclusions/results.
• Read and understand intermediate level mechanical and electrical drawings and P&ID’s.
• Experience with Microsoft products, Minitab, and CAD software packages.
• Understand safe work practices and experience in lockout, tag out, electrical safety, etc.
• Lean/Six Sigma experience, with green or black belt.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!