GMP Validation Engineer – CQV for Cell & Gene Therapy

Vertex Pharmaceuticals LLC; Boston (MA); On-site; USD 76,000 - 83,000; Full time

Job summary

Vertex Pharmaceuticals LLC is seeking a Validation Engineer for its Cell and Gene Therapies Facility in South Boston and Cambridge. The role involves commissioning, qualification and validation activities under the VCGT Validation leadership to support aseptic operations and GMP manufacturing.

The ideal candidate has 1-3 years of aseptic validation experience, a B.S. in Engineering or related discipline, and the ability to work off-shift hours.

Qualifications

• 1-3 years experience in aseptic operations and validation (systems level).
• Experience developing and executing Validation protocols in GMP Manufacturing and Analytical Laboratory environments.
• Flexibility for off-shift hours, including weekends and nights.
• Understanding of GMP, ISO, GAMP, ANSI concepts is desired.

Responsibilities

• Draft and implement Quality System documentation to establish validation practices.
• Author URS, IQ, OQ and PQ protocols and execute them per GDP and internal standards.
• Support qualification of Analytical Instrument and Manufacturing equipment.
• Coordinate with vendors and internal stakeholders to schedule CQV activities and test plans.
• Ensure validation activities align with Vertex SOPs and global standards.

Skills

Aseptic operations

Validation

GMP/ISO/GAMP knowledge

Cross-functional collaboration

Education

B.S. in Engineering or related discipline

Job description

Vertex Pharmaceuticals LLC is seeking a Validation Engineer for its Cell and Gene Therapies Facility in South Boston and Cambridge. The role involves commissioning, qualification and validation activities under the VCGT Validation leadership to support aseptic operations and GMP manufacturing.

The ideal candidate has 1-3 years of aseptic validation experience, a B.S. in Engineering or related discipline, and the ability to work off-shift hours.