Assistant Process Engineer # 26-26899

Us Tech Solutions; Harvard (MA); Presencial; USD 41.000 - 48.000; Jornada completa

Descripción de la vacante

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.

Formación

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

Responsabilidades

• 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.

Conocimientos

Biopharma operations

cGMP knowledge

Communication skills

Educación

Bachelor’s degree in science/engineering/biochemistry

Descripción del empleo

$30-$35 per hour

Devens, MA

Contract

Duration: 06 Months Contract

Job Description:

• 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.

Responsibilities:

• Responsible for oversight of CTF Process Validation activities including, but not limited to Aseptic Process Simulations/ Validations (Client/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.

Experience:

• A minimum of 2 years’ experience in biopharmaceutical operations, or its equivalent is required

Skillsets:

• Experience in cGMP’s and multi-national biopharmaceutical/cell therapy regulations
• Excellent verbal/written communication skills

Education:

• Bachelor’s degree in science, engineering, biochemistry or related discipline, is required.

AI Statement:

By applying, you acknowledge that AI-assisted tools may be used during hiring.

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.