Senior Technical Lead

Job Summary

Experienced professionals will find a full-time Senior Technical Lead opportunity focused on guiding and mentoring junior resources in the Pharmaceutical, biotechnology, or medical device industry, with responsibilities including validation documentation and compliance in a regulated environment, while working onshore or nearshore.

Key Responsibilities

• Oversee and execute validation documentation for compliance and validation plans, test protocols, and reports
• Review system test and user acceptance test scripts, ensuring adherence to QA methodologies and GxP standards
• Provide validation guidance and timely reviews, while leading teams and managing multiple projects simultaneously

Required Qualifications

• 3-7 years of relevant experience in the Pharmaceutical, biotechnology, or medical device industry
• Previous experience with Computer System Validation in FDA-regulated environments
• Strong knowledge of FDA guidance and industry standards such as GAMP
• Hands-on experience with Data Solutions validation, including familiarity with Snowflake and Databricks
• Ability to work independently and collaboratively with remote teams