Sr. Validation Engineer

MilliporeSigma; Indianapolis (IN); On-site; USD 111,000 - 167,000; Full time

Benefits offered by this job

Health insurance

PTO

Retirement contributions

Bonuses possible

Job summary

MilliporeSigma in Indianapolis is seeking a Sr. Validation Engineer to own the validation program for a complex aseptic manufacturing site, focusing on the cleaning validation program.

You will author and execute validation protocols spanning process, equipment, facility, utilities, and computerized systems with substantial autonomy. You will lead cross-functional validation projects, develop validation master plans, and support media fills while reviewing data for management approval to ensure

Qualifications

• B.S. in science or engineering with 7+ years validation in aseptic pharma.
• Experience with aseptic bulk process formulation, aseptic filling, process and packaging equipment, computer systems, process control systems, equipment cleaning and sterility assurance.

Responsibilities

• Lead and execute validation activities across aseptic manufacturing.
• Develop and implement validation master plans and protocols.
• Coordinate cross-functional validation projects and change controls.
• Support media fills and revalidation activities.

Skills

Validation experience

Aseptic processes

Process equipment

Quality systems

Regulatory compliance

Statistical analysis

Education

B.S. in science or engineering

Tools

Kaye Validator

Val Probe

PLC

Temperature standards

Pressure standards

Job 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.

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

Your Role

Validation is the backbone of pharmaceutical manufacturing quality — and in this role, you will own it. As a Sr. Validation Engineer, you will lead and execute validation activities across a complex aseptic manufacturing site, with a primary focus on the cleaning validation program. You will research, author, coordinate, and execute validation protocols covering process, equipment, facility, utilities, computerized systems, and cleaning. Working with considerable autonomy, you will review and summarize data for management approval, perform revalidations, assess the impact of change control requests, and create and update standard operating procedures. You will also serve as validation lead on cross-functional projects, develop validation master plans, and support media fills. Your technical depth and independent judgement will directly protect product quality and regulatory compliance.

Who You Are

Minimum Qualifications

• B.S. in science or engineering related field and 7 years validation experience or equivalent combination of two-year degree and a minimum of 9 years validation experience in an aseptic pharmaceutical setting focused on equipment cleaning (automated and manual).
• Experience with aseptic bulk process formulation, aseptic filling, process and packaging equipment, computer systems, process control systems, equipment cleaning and sterility assurance required.

Preferred Qualifications

• Experience with various types of validation test equipment, such as: Kaye Validator, Val Probe, PLC, Temperature/Pressure standards.
• Prior experience (required) 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
• Cleaning Validation
• Hands-on skills are necessary.
• Expertise with Windows based Personal Computers.
• Above average PC skills with spreadsheets, word processing and databases.
• Employee must be self-motivated, highly organized, and conscientious.
• Must be able to work and make decisions independently as well as with a team.
• Must be able to work in technically and mentally demanding situations.
• Strong verbal and written communications skills are required.
• This role requires regular access to process areas by climbing stairs and ladders and performing work in those areas.
• Employee must be available to work various shifts and weekends to support the Validation Schedule.
• Proficiency with statistical analysis tools and the ability to interpret and present complex data sets.

Pay Range for this position: $111,200 - $166,800

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.

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!