Biotech Downstream Validation Engineer

MENTOR Technical Group Corporation; United States; On-site; USD 75,000 - 95,000; Full time

Job summary

MENTOR Technical Group Corporation is seeking a Validation Specialist for their biotech downstream process equipment. The role involves developing and executing validation protocols, performing risk assessments, and collaborating with various teams to ensure regulatory compliance.

Ideal candidates will have a Bachelor’s degree in a relevant field, 3–5 years of experience in process validation, and strong knowledge of cGMP and FDA guidelines. This position is a full-time opportunity based in the United States.

Qualifications

• Minimum 3–5 years of experience in validation of biotech downstream process equipment.
• Strong knowledge of cGMP, FDA, and ICH guidelines.
• Experience with IQ/OQ/PQ protocols and validation documentation.

Responsibilities

• Develop, review, and execute validation protocols for downstream process equipment.
• Perform risk assessments and validation reports for equipment.
• Collaborate with engineering, QA, and operations teams.

Skills

Problem-solving

Communication

Organization

Education

Bachelor’s degree in Biotechnology, Biochemistry, Chemical Engineering, or related field

Job description

MENTOR Technical Group Corporation is seeking a Validation Specialist for their biotech downstream process equipment. The role involves developing and executing validation protocols, performing risk assessments, and collaborating with various teams to ensure regulatory compliance.

Ideal candidates will have a Bachelor’s degree in a relevant field, 3–5 years of experience in process validation, and strong knowledge of cGMP and FDA guidelines. This position is a full-time opportunity based in the United States.