Engineering - Assistant Process Engineer

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

Position Title: Assistant Process Engineer
Work Location: Devens, MA
Assignment Duration: 6 months
Work Schedule: Mon-Fri (normal business hours)
Work Arrangement: Hybrid (50% onsite required)

Position Summary

• The Senior Specialist, MS&T Validation provides process validation support to the Devens Cell Therapy Facility (CTF). The Senior Specialist participates in facility, process, and aseptic validation activities, including support of the Aseptic Process Simulation Program and implementation of process lifecycle management changes.

Key Responsibilities

• Responsible for oversight of CTF Process Validation activities including, but not limited to Aseptic Process Simulations/ Validations (APS/APV), and other Lifecycle Management changes.
• Prepares written protocols/reports/summaries supporting validation studies.
• Ensures safe and compliant cGMP operations, maintains permanent inspection readiness.
• This position reports to the Associate Director of Manufacturing Science and Technology Validation.

Qualification & Experience

• Experience in cGMP's and multi-national biopharmaceutical/cell therapy regulations
• Excellent verbal/written communication skills
• Knowledge of science generally attained through studies resulting in a Bachelor's degree in science, engineering, biochemistry or related discipline, is required
• A minimum of 2 years' experience in biopharmaceutical operations, or its equivalent is required.