Our client, a leading pharmaceutical/biotech company, is hiring a QA & Validation Associate.

Work Location: Middlesex County, Massachusetts

Summary:

This role provides hands-on support across both the Validation and Quality Assurance functions within a regulated pharmaceutical/biotech environment. The associate will support validation activities (facility, equipment, cleaning) while also contributing to quality system operations and audit readiness.

Responsibilities:

• Lead and/or support validation activities including planning, protocol development, execution, data analysis, and final report writing for facility, equipment, and cleaning validations.
• Perform temperature mapping studies using Kaye ValProbe RT / Validator AVS systems and Vaisala data loggers.
• Support or execute cleaning validation sampling.
• Collaborate cross-functionally with Facilities, Manufacturing, and QC teams to design and execute validation strategies, with an initial focus on temperature mapping, sterilization, and cleaning validation.
• Review and approve validation protocols and associated documentation.
• Maintain tracking tools and spreadsheets supporting quality system activities.
• Support QA team members with day-to-day quality operations as needed.
• Assist in audit preparation for regulatory inspections.
• Perform additional quality-related duties as assigned.

Qualifications:

• Experience planning and executing equipment and facility validation in a regulated pharma/biotech environment.
• Hands-on experience with Kaye validators, Vaisala data loggers, and cleaning validation tools/assays.
• Working knowledge of validation methodologies with the ability to contribute to method development.
• Strong technical writing skills (protocols, reports, documentation).
• Foundational knowledge of US and EU regulatory expectations (e.g., FDA, EMA, GMP).
• Ability to work independently with minimal supervision while also contributing effectively within a team.
• Strong problem-solving skills and sound judgment.
• High attention to detail, strong ownership, and accountability.
• Proficient in Microsoft Word and Excel.
• Strong written and verbal communication skills in English.
• Role may involve working in laboratories and production environments, including use of fume hoods and biosafety cabinets.
• Some physical activity required (standing, walking, light lifting, bending, working around equipment).
• May involve working near hot equipment or steam systems.
• Gowning required for certain areas.
• Occasional movement between facilities may be required.
• Bachelor’s degree (or Associate’s degree with relevant experience).
• 1–3 years of industry experience in validation, QA, or GMP-regulated environments.

Published Category: Quality & Validation