CQV Engineer

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

We are seeking a motivated CQV Engineer with 0-3 years of experience to support Commissioning, Qualification, and Validation (CQV) activities within pharmaceutical, biotechnology, and other regulated life-sciences manufacturing environments. The role will provide hands-on exposure to equipment, facility, utility, and process qualification, including IQ/OQ/PQ execution, commissioning activities, system walkdowns, protocol development, and qualification documentation.

The CQV Engineer will work closely with Engineering, Validation, Quality, Manufacturing, Automation, and Project teams to ensure systems and equipment are properly commissioned, qualified, documented, and compliant with applicable cGMP requirements. This position is well suited for an early-career engineer looking to build a strong foundation in CQV, validation, commissioning, and pharmaceutical engineering.

Key Responsibilities

• Support Commissioning, Qualification, and Validation activities for pharmaceutical and biotech facilities.
• Assist with development and execution of IQ, OQ, and PQ protocols.
• Support preparation and review of URS, FRS, design specifications, test scripts, and qualification documentation.
• Participate in equipment and system walkdowns, field verification, and punch-list activities.
• Support qualification of process equipment, utilities, clean utilities, and manufacturing systems.
• Assist with commissioning, startup, functional testing, and system turnover activities.
• Support deviation, discrepancy, change control, and CAPA activities.
• Review engineering, vendor, and technical documentation for qualification readiness.
• Maintain accurate documentation in accordance with cGMP and data-integrity requirements.
• Collaborate with Engineering, Quality, Manufacturing, Validation, and Project teams.
• Support execution of qualification activities according to project schedules and established procedures.

Required Qualifications

• Bachelor's degree in Chemical, Mechanical, Electrical, Biomedical, Pharmaceutical, or related Engineering.
• 0-3 years of experience in CQV, validation, commissioning, manufacturing, engineering, or a related field.
• Basic understanding of cGMP and regulated manufacturing environments.
• Understanding of IQ/OQ/PQ and qualification concepts.
• Strong documentation, communication, analytical, and problem-solving skills.
• Ability to work in a hands-on/site-based environment.

Preferred Qualifications

• Exposure to GAMP 5, 21 CFR Part 11, EU GMP, or data-integrity principles.
• Familiarity with URS/FRS, risk assessments, traceability matrices, and validation protocols.
• Exposure to pharmaceutical equipment such as bioreactors, vessels, pumps, CIP/SIP systems, filtration systems, chromatography systems, and process skids.