Software Validation Engineer

Work Location:  St. Louis, Missouri
Shift:  No
Department:  LS-QR-DV Validation Management
Recruiter:  Michelle Cole

This information is for internals only. Please do not share outside of the organization.

Your Role:

As a Software Validation Engineer at MilliporeSigma, you will guide and direct validation projects for all Life Science digital products, applications, and computerized systems. You will serve as a subject matter expert, providing leadership on computerized systems validation, quality governance, and regulatory compliance, including travel for critical site support during inspections or major projects. Responsibilities include the following:

• Lead the qualification and validation of diverse digital products, computerized systems, and software solutions, including Control Systems, Cloud-based solutions, and Operational Technology (OT)
• Execute the full validation lifecycle (IQ, OQ, PQ, protocols, test scripts, infrastructure qualification, backup/restoration, and audit trail testing) in both GMP and Non-GMP environments
• Ensure compliance with global regulatory guidelines including GAMP, QMS, 21 CFR Part 11, and Annex 11
• Perform critical assessments (Risk, Functional Risk, Data Integrity, FMEA) to define requirements and controls prior to development and verify tested systems meet those standards
• Review and approve validation documentation, including URS, Functional/Design Specifications, and Test Scripts for COTS and new products
• Develop and manage core validation documents, such as Test Scripts/Protocols, Test Summary Reports, Traceability Matrices, and Validation Summary Reports
• Manage quality system activities, including Operational Change Control, Deviation/CAPA management, customer complaint handling, and periodic review/re-validation
• Act as the validation expert during audits, effectively presenting and explaining qualification documents and reports to regulatory agencies, internal/external auditors, and customers
• This is a hybrid role including 3 days on-site and 2 days remote work

Who You Are

Minimum Qualifications:

• Bachelor's degree in Chemistry, Chemical Engineering, Computer Science, Biomedical engineering or other Life Science discipline
• 5+ years of experience in software and/or computerized validation 

Preferred Qualifications:

• Excellent written and verbal skills
• Prior automation testing experience
• Excellent computer skills and experience in Project Planning, Word, Excel, PowerPoint, SharePoint
• Qualified systems and supported process validation, ensuring compliance with GMP, GCP, GLP, GAMP, and Part 11 regulations
• Global travel based on the need of project and business

Salary range for this position - $66, $109,300.00 annually

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. 

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.