CQV Engineer: Pharma Validation & Commissioning

GxP Associates; New Jersey; On-site; USD 60,000 - 90,000; Full time

Job summary

GxP Associates in New Jersey seeks a motivated CQV Engineer with 0-3 years to support Commissioning, Qualification, and Validation activities across regulated life-sciences facilities. You will gain hands-on exposure to IQ/OQ/PQ execution, equipment and system qualification, and documentation.

You will collaborate with Engineering, Validation, Quality, Manufacturing, and Project teams to ensure systems are properly commissioned and compliant with cGMP.

Qualifications

• Bachelor’s degree in a relevant engineering field.
• 0–3 years experience in CQV, validation, or related fields.
• Knowledge of cGMP regulated environments.
• Understanding IQ/OQ/PQ concepts.
• Strong documentation and communication skills.
• Willingness to work hands-on at sites.

Responsibilities

• Support CQV activities for pharmaceutical and biotech facilities.
• Assist development and execution of IQ, OQ, and PQ protocols.
• Support review of URS, FRS, design specs, test scripts, and qualification docs.
• Participate in equipment/system walkdowns, field verification, and punch-lists.
• Support qualification of process equipment, utilities, clean utilities, and manufacturing systems.
• Assist commissioning, startup, functional testing, and system turnover.
• Support deviation, discrepancy, change control, and CAPA activities.
• Review engineering/vendor docs for qualification readiness.
• Maintain accurate docs per cGMP and data-integrity.
• Collaborate with Engineering, Quality, Manufacturing, Validation, and Project teams.
• Support execution of qualification activities per schedules and procedures.

Skills

CQV Engineering

Validation

Commissioning

Documentation

Teamwork

Problem Solving

Education

Bachelor's degree in Chemical, Mechanical, Electrical, Biomedical, Pharmaceutical, or related Engineering

Job description

GxP Associates in New Jersey seeks a motivated CQV Engineer with 0-3 years to support Commissioning, Qualification, and Validation activities across regulated life-sciences facilities. You will gain hands-on exposure to IQ/OQ/PQ execution, equipment and system qualification, and documentation.

You will collaborate with Engineering, Validation, Quality, Manufacturing, and Project teams to ensure systems are properly commissioned and compliant with cGMP.