Process Validation Engineer - Aseptic Cell Therapy Contract

Us Tech Solutions; Harvard (MA); On-site; USD 41,000 - 48,000; Full time

Job summary

US Tech Solutions is seeking a Senior Specialist, MS&T Validation to support the Devens Cell Therapy Facility. The role covers process validation, aseptic validation, and lifecycle management changes.

Responsibilities include oversight of validation activities, writing protocols and reports, ensuring safe, compliant cGMP operations, and maintaining inspection readiness. A BS in science/engineering is required.

Qualifications

• Bachelor’s degree in science, engineering, biochemistry or related discipline.
• 2+ years in biopharmaceutical operations and cGMP knowledge.
• Excellent verbal and written communication skills.

Responsibilities

• Oversee validation activities for CTF Process Validation including Aseptic Process Simulations/Validations and Lifecycle Management changes.
• Prepare written protocols, reports and summaries supporting validation studies.
• Ensure safe and compliant cGMP operations and maintain inspection readiness.

Skills

Biopharma operations

cGMP knowledge

Communication skills

Education

Bachelor’s degree in science/engineering/biochemistry

Job description

US Tech Solutions is seeking a Senior Specialist, MS&T Validation to support the Devens Cell Therapy Facility. The role covers process validation, aseptic validation, and lifecycle management changes.

Responsibilities include oversight of validation activities, writing protocols and reports, ensuring safe, compliant cGMP operations, and maintaining inspection readiness. A BS in science/engineering is required.