Validation Engineers II

MilliporeSigma; Indianapolis (IN); On-site; USD 60,000 - 100,000; Full time

Job summary

An innovative firm is seeking a Validation Engineer II who will play a crucial role in ensuring compliance with industry standards in an aseptic pharmaceutical environment. This position involves executing validation protocols, analyzing data, and creating Standard Operating Procedures. The ideal candidate will have a strong background in validation processes and a passion for quality and compliance. Join a diverse team that values curiosity and innovation, and contribute to impactful projects that enhance healthcare and technology. Your expertise will help drive excellence and champion human progress in a collaborative work environment.

Qualifications

• Bachelor's degree required; Master's degree accepted with less experience.
• 5+ years in validation engineering or related field in pharmaceuticals.

Responsibilities

• Support validation activities ensuring compliance with cGMP and FDA regulations.
• Write and execute validation protocols for various processes and equipment.

Skills

Validation Protocols

Statistical Analysis

Process Validation

Cleaning Validation

Aseptic Techniques

Education

Bachelor's degree in Engineering

Master's degree in Engineering

Tools

Kaye Validator

Val Probe

PLC Software

Temperature Mapping Equipment

Job description

Join to apply for the Validation Engineers II role at MilliporeSigma.

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.

Job Title: Validation Engineers II

Employer: Exelead Inc., 400 Summit Drive, Burlington, MA 01803

Job Location: Exelead Inc., 6815 Guion Rd., Indianapolis, IN 46268

This position is eligible for the Exelead Inc. Employee Referral Program.

Job Responsibilities

The Validation Engineer II is responsible for providing support to all validation activities at our Indianapolis worksite. The position is responsible for compliance with all applicable cGMP, FDA, and EU regulations as they pertain to validation (21 CFR 210 & 211; 21 CFR Part 11; EU GMPs; ICH Q7, Q8, Q9, Q10).

Specific Duties Include The Following

• Research, write, coordinate, and execute validation protocols including IQ, OQ, PQ for process, equipment, facility, utility, computer, and cleaning validation;
• Execute validation test functions in support of approved protocols;
• Review, summarize and present data in a Summary Report for management review and approval, and perform revalidations;
• Use validation test equipment such as Kaye Validator, Val Probe, PLC Software such as A-B and Honeywell, and Heat Blocks;
• Acquire and demonstrate the ability to use site documentation systems such as: Quality Tracking System, Document management systems, Training, Maintenance management etc.;
• Review and recommend impact of change control requests;
• Apply statistical tools and analyze results and raw data;
• Participate in projects for new systems and equipment;
• Review process changes and validation in support of Annual Product reviews;
• Create Standard Operating Procedures (SOPs) for new equipment/processes, as well as update existing SOPs;
• Perform peer review of all validation documents.

Job Requirements

Employer requires candidate to have a Bachelor’s degree in Engineering or a closely related science field and five (5) years of progressively more responsible work experience in a validation engineer or closely related occupation in an aseptic pharmaceutical setting. Alternatively, employer will accept a Master’s degree in Engineering or a closely related science field and two (2) years of work experience in a validation engineer or closely related occupation in an aseptic pharmaceutical setting.

Candidate Must Also Have The Following

• Demonstrated ability 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.), and Pharmaceutical-Grade Utilities gained through two (2) years of work experience;
• Demonstrated knowledge of various types of validation test equipment, such as Kaye Validator, Val Probe, PLC, and Temperature/Pressure standards gained through two (2) years of work experience;
• Demonstrated ability with process validation and cleaning validation gained through two (2) years of work experience;
• Demonstrated ability researching, writing, coordinating, and executing validation protocols including IQ, OQ, and PQ for process, equipment, facility, utility, computer, and cleaning validation gained through two (2) years of work experience;
• Demonstrated ability creating Standard Operating Procedures (SOPs) for new equipment/processes, as well as updating existing SOPs gained through two (2) years of work experience.

Must be willing to work late-night and/or weekend shifts approximately 2-4 times a month to support the Validation Schedule.

All years of experience may be gained concurrently.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it 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 our diverse team!