Validation Specialist

Merck • Burlington, MA

2d • Onsite

About The Position

As a Validation Specialist for Bacterial Retention, you will execute microbial filter validation tests, plan testing runs, and maintain compliant documentation, while applying aseptic techniques in a sterile environment. You will read and follow SOPs, coordinate with the Lab Manager and Project Manager, and ensure data integrity through accurate record-keeping and timely communication. The purpose of this role solves the challenge of ensuring robust bacterial retention validation data and compliant documentation by executing validated plans, adhering to SOPs, maintaining data integrity, and coordinating with cross-functional teams to meet project timelines. Currently, our team consists of 6 members with a structure of 2 validation specialists and 4 sr. validation specialists. The role is based in Burlington, MA. This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Requirements

• Associate Degree in a life science discipline (Microbiology, Chemistry, etc.)
• 1+ years' experience in a bacterial retention validation or microbiology retention role
• Eligible to work in the US

Nice To Haves

• Bachelor's Degree in a life science discipline (Microbiology, Chemistry, etc.)
• Proficiency in Good Documentation Practices and ALCOA+ principles
• Experience with validation activities such as cleanroom aseptic technique, filter validation, and test plan development
• Experience using laboratory software and tools (Excel, Word, LabVantage, Smartsheet)
• Strong collaboration across cross-functional teams including Quality Assurance, microbiology, and manufacturing
• Detail-oriented with solid data analysis and troubleshooting skills
• Knowledge of GLP/GMP practices and ISO 9001:2015 standards
• Commitment to continuous improvement and maintaining a safe, organized work environment

Responsibilities

• Execute microbial filter validation tests
• Plan testing runs
• Maintain compliant documentation
• Apply aseptic techniques in a sterile environment
• Read and follow SOPs
• Coordinate with the Lab Manager and Project Manager
• Ensure data integrity through accurate record-keeping and timely communication

Benefits

• health insurance
• paid time off (PTO)
• retirement contributions
• other perquisites

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree