Validation Engineer

United Consulting Hub; New Jersey; On-site; USD 60,000 - 80,000; Full time

Job summary

United Consulting Hub is looking for an Entry-Level Validation Engineer to support validation activities in pharmaceutical, biotechnology, and medical device environments. The candidate will assist in executing IQ, OQ, and PQ protocols, ensuring compliance with GMP and FDA regulations.

A Bachelor's degree in a related field is required, along with strong documentation and communication skills. This role is a great opportunity for recent graduates or those with limited experience in regulated industries.

Qualifications

• 0–2 years of validation or quality experience in a regulated environment.
• Basic understanding of GMP/cGMP and validation lifecycle.
• Strong documentation and communication skills.

Responsibilities

• Assist in execution of IQ, OQ, and PQ protocols.
• Support equipment and process validation activities.
• Maintain compliance with GMP and FDA regulations.

Skills

Documentation skills

Communication skills

Analytical skills

Teamwork

Education

Bachelor's degree in Pharmacy or Life Sciences

Job description

We are seeking an Entry-Level Validation Engineer with a background in Pharmacy, Life Sciences, or Engineering to support validation activities within pharmaceutical, biotechnology, and medical device environments.

Key Responsibilities

• Assist in execution of IQ, OQ, and PQ protocols
• Support equipment, process, and cleaning validation activities
• Prepare, review, and maintain validation documentation and reports
• Ensure compliance with GMP, FDA regulations, and 21 CFR Part 11
• Collaborate with Quality Assurance, Manufacturing, and Engineering teams
• Support deviation investigations, non-conformance documentation, and CAPA activities
• Participate in audits and inspection readiness activities
• Maintain data integrity and compliance documentation

Required Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, Biotechnology, Biomedical Engineering, Chemical Engineering, or related field
• 0–2 years of validation, quality, or regulated industry experience
• Basic understanding of GMP/cGMP and validation lifecycle concepts
• Strong documentation, communication, and analytical skills
• Ability to work in a team-oriented environment

Preferred Skills

• Knowledge of IQ/OQ/PQ protocols
• Exposure to pharmaceutical, biotech, or medical device environments
• Familiarity with CAPA, deviations, and change controls
• Understanding of FDA regulations and compliance requirements