Miamisburg, Ohio
4 days ago
Validation Engineer

 

Work Your Magic with us! Start your next chapter and join MilliporeSigma.

 

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:

 

In this role you will develop and execute validation protocols to ensure compliance with Good Manufacturing Practices (GMP) and regulatory requirements. This role is crucial for maintaining the quality and integrity of manufacturing processes and products.

 

Key Responsibilities:

 

Develop and execute all validation activities for the facility, including planning, scheduling, execution, and project communication.Act as a key member of multi-department teams as the Validation representative, facilitating the introduction of new products/processes and troubleshooting existing ones.Proactively identify process operating problems and opportunities for improvement, developing innovative and cost-effective solutions.Create and execute validation protocols for equipment, analytical instrumentation, cleaning processes, and facilities, including FAT, SAT, IQ, and PQ documents.Maintain validation records and report metrics to site leadership, ensuring compliance with regulatory guidelines (FDA, EU, ISO, ISPE, 21 CFR Part 11).Collaborate with production operators, engineers, quality assurance staff, and contractors to coordinate validation schedules and execution efforts.

 

Physical Attributes:

 

Wear Personal Protective Equipment for the duration of the shift.Lift up to 50 pounds.

 

Who You Are:

 

Minimum Qualifications:

 

Bachelor’s Degree in Chemical Engineering, Electrical Engineering, or other Engineering discipline.3+ years of quality or validation experience in a cGMP pharmaceutical setting.

 

Preferred Qualifications:

 

Experience with FDA and European regulatory guidelines.Strong leadership and communication skills.Experience with CAD software.Experience with Microsoft Project scheduling software.

 


 

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!

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