Hybrid Assistant Process Engineer – Validation (Biopharma)

Spectraforce Technologies, Inc.; Harvard (MA); Hybrid; USD 90,000 - 120,000; Full time

Job summary

Spectraforce Technologies, Inc. is seeking a Senior Specialist MS&T Validation for the Devens, MA facility. The role supports process validation activities, including aseptic validation and process lifecycle management, in a hybrid 50% onsite setting.

The assignment lasts 6 months, with Mon-Fri hours and a focus on quality and compliance. Ideal candidates will have at least 2 years in biopharmaceutical operations, solid cGMP knowledge, and strong written/verbal communication skills to drive

Qualifications

• Experience in cGMP's and multi-national biopharmaceutical/cell therapy regulations.
• Excellent verbal/written communication skills.
• Bachelor's degree in science/engineering/biochemistry or related discipline is required.
• Minimum of 2 years' experience in biopharmaceutical operations or equivalent is required.

Responsibilities

• Oversee CTF Process Validation activities including APS/APV and other Lifecycle Management changes.
• Prepare written protocols/reports/summaries supporting validation studies.
• Ensure safe and compliant cGMP operations and maintain inspection readiness.
• Report to the Associate Director of Manufacturing Science and Technology Validation.

Skills

cGMP

Validation

Communication

Education

Bachelor's degree in science/engineering/biochemistry

Job description

Spectraforce Technologies, Inc. is seeking a Senior Specialist MS&T Validation for the Devens, MA facility. The role supports process validation activities, including aseptic validation and process lifecycle management, in a hybrid 50% onsite setting.

The assignment lasts 6 months, with Mon-Fri hours and a focus on quality and compliance. Ideal candidates will have at least 2 years in biopharmaceutical operations, solid cGMP knowledge, and strong written/verbal communication skills to drive