Digital Platform Senior Validation Engineer

Merck Gruppe; St. Louis (MO); On-site; USD 70,000 - 110,000; Full time

Job summary

An established industry player is seeking a Digital Platform Senior Validation Engineer to lead validation projects for innovative Life Science digital products. This role focuses on developing automated devices for chemical synthesis and sample preparation, ensuring robust and precise systems. With a commitment to quality and compliance, you will review regulatory requirements, perform risk assessments, and manage deviations. Join a dynamic team that values your expertise and offers a collaborative environment to drive impactful projects in the Life Sciences sector.

Qualifications

• 5+ years of software or computerized validation experience.
• Knowledge of GMPs, GCPs, GLPs, GAMP, and Part 11 compliance.

Responsibilities

• Guide validation projects for Life Science digital products and applications.
• Develop Test Summary Reports, Traceability Matrices, and Validation Summary Reports.

Skills

Software Validation

Risk Assessments

Data Integrity Assessments

FMEA

Project Planning

Education

Bachelor’s degree in Life Science

Bachelor’s degree in Engineering

Bachelor’s degree in Computer Science

Tools

Word

Excel

PowerPoint

SharePoint

Job description

Work Location:

St. Louis, Missouri

Shift:

No

Department:

LS-QR-DV Validation Management

Recruiter:

Kathy Lewison

Hiring Manager:

Anbukumar Marimuthu

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

Your Role:

You will be the Digital Platform Senior Validation Engineer, responsible for guiding validation projects for all Life Science digital products, applications, and computerized systems. Your main focus will be developing automated devices and instrumentation for chemical synthesis and sample preparation, ensuring these systems are robust, precise, and scalable.

Responsibilities include but are not limited to:

1. Reviewing regulatory requirements based on system needs and target market scope, in GMP and Non-GMP areas.
2. Performing 21 CFR Part 11, Annex 11, Risk Assessments, Data Integrity Assessments, FMEA, and ensuring requirements and controls are captured and met.
3. Developing Test Summary Reports, Traceability Matrices, Validation Summary Reports, QMS, Data Integrity White papers, IQ, OQ Protocols, FAT, and managing deviations and observations.
4. Leading operational change control, deviation, CAPA management, handling customer complaints, periodic reviews, re-validation of digital products and software, and presenting validation reports to auditors.

Who You Are:

Minimum Qualifications:

• Bachelor’s degree in Life Science (Chemistry, Biology, etc.) or Engineering (Chemical, Mechanical, etc.) or Computer Science.
• 5+ years of software or computerized validation experience.

Preferred Qualifications:

• Experience with project planning, Word, Excel, PowerPoint, SharePoint.
• Knowledge of GMPs, GCPs, GLPs, GAMP, and Part 11 compliance related to system qualification and validation processes.

RSREMD

The company is an Equal Employment Opportunity employer. Discrimination based on race, color, religion, age, sex, sexual orientation, national origin, disability, veteran status, genetic information, gender identity, marital status, or other protected classes is prohibited. Concerns about discrimination should be reported to HR, Legal, or Compliance. The company will not retaliate against individuals reporting discrimination in good faith.