Validation Engineer 2

Job Number: 1455

External Description: 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.

Your Role:

In this role you are responsible for providing support to all validation activities within the Indianapolis site.

Responsibilities include but are not limited to:

• Ensure compliance with all applicable cGMP, FDA, and EU regulations related to validation.
• Create and execute validation protocols and reports for equipment, facilities, utilities, processes, and computer systems.
• Perform revalidations and recommend plans to maintain systems in a compliant, validated state.
• Analyze data using statistical tools and present it in summary reports for management review.
• Manage changes by reviewing and recommending the validation impact of change control requests and critical system work orders.
• Support projects by acting as a project lead, assisting with new systems, and creating validation master plans.
• Develop documentation including creating new Standard Operating Procedures (SOPs) and updating existing ones.
• Collaborate with teams to perform peer reviews of validation documents and support annual product reviews and media fills.

Who You Are:

Minimum Qualifications:

• Bachelor's Degree in Biology, Chemistry, Chemical Engineering, Electrical Engineering, or other Life Science or Engineering discipline and 3+ years' of validation work experience in aseptic pharmaceutical setting.

OR

• Associate's Degree in Biology, Chemistry, Chemical Engineering, Electrical Engineering, or other Life Science or Engineering and 5+ years' of validation work experience in aseptic pharmaceutical setting.

Preferred Qualifications:

• Experience with aseptic bulk process formulation, aseptic filling, process and packaging validation equipment, computer systems, process control systems, equipment cleaning, and sterility assurance.
• Experience with various types of validation test equipment, such as: Kaye Validator, Val Probe, PLC, Temperature/Pressure standards.
• Prior experience in the qualification of various types of sterile filling facility equipment, such as Sterilization Technology (Steam, Dry Heat, VHP, etc), Temperature Mapping (Various chambers), Aseptic Equipment (Washers, Tunnels, Cappers, RABS, Isolators etc), Pharmaceutical Grade Utilities Process Validation, or Cleaning Validation.
• Experience with Windows based Personal Computers.
• PC skills with spreadsheets, word processing and databases.
• Highly organized, conscientious, and self-motivated.
• Strong verbal and written communications skills.

Pay Range for this position: $72,700 - $118,700 / year

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here .

RSREMD

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!

Job Number: 291198

Community / Marketing Title: Validation Engineer 2

Location_formattedLocationLong: Indianapolis, Indiana US