Cell Therapy QA Validation Specialist (6-Month Contract)

Belcan Corporation; Westborough (MA); On-site; USD 79,000 - 80,000; Full time

Job summary

Belcan Corporation in Westborough, MA, is seeking a Validation Contractor in Quality Assurance to support cGMP cell therapy manufacturing validation. This on-site role executes validation strategies for equipment and systems, ensuring compliance with 21 CFR Part 11, EU Annex 11, and GAMP 5 across manufacturing, QC, and facilities teams.

The candidate should have GxP experience, strong technical writing, and the ability to manage multiple validation projects in a regulated environment.

Qualifications

• Experience in biologics, cell therapy and/or gene therapy in a GxP environment.
• Knowledge of GAMP 5, 21 CFR Part 11 / EU Annex 11.
• Experience drafting and reviewing validation lifecycle documents for lab equipment.

Responsibilities

• Execute Validation Strategy for clinical and pre-commercial cell therapy manufacturing.
• Validate equipment, computerized systems, and facilities; ensure 21 CFR Part 11 and EU Annex 11 compliance.
• Collaborate with manufacturing, QC, cytogenomics and materials management on validation activities.
• -author protocols and reports; maintain documentation per good practices.
• Interface with stakeholders to test user and compliance requirements.

Skills

GxP experience

Technical writing

Data integrity

Risk assessment

Cross-functional collaboration

Education

BS/BA in Life Sciences

BS/BA in Engineering

BS/BA in Chemistry

Tools

KAYE Validator

Ellab ValSuite

Electronic document management system

Job description

Belcan Corporation in Westborough, MA, is seeking a Validation Contractor in Quality Assurance to support cGMP cell therapy manufacturing validation. This on-site role executes validation strategies for equipment and systems, ensuring compliance with 21 CFR Part 11, EU Annex 11, and GAMP 5 across manufacturing, QC, and facilities teams.

The candidate should have GxP experience, strong technical writing, and the ability to manage multiple validation projects in a regulated environment.