CQV Engineer (Equipment)

CQV Engineer (Equipment) at White Collar Technologies, Inc CQV Engineer (Equipment) at White Collar Technologies, Inc in Columbus, Ohio Posted in about 24 hours ago.

Type:

full-time

Job Description:

Company Description White Collar Technologies, Inc. is a boutique human capital consultancy firm specializing in IT and engineering solutions within the life sciences sector. We collaborate with a diverse range of clients in the Pharmaceutical, Biotech, Medical Device, Clinical Research, and Healthcare industries. Our expertise lies in cGxP/GAMP/21 CFR Part 11 compliance, scientific business analysis, quality assurance, computer system validation, lab instrument validation, regulatory affairs, and production support. We are committed to delivering exceptional consulting services tailored to meet the unique challenges of our clients in highly regulated industries.

Role Description Location:

Columbus, OH (Onsite - 5 days/week)

Employment Type:

Full-time /

Contract Experience Required:

Minimum 3 years in

Equipment/Facility/Utilities Validation Critical Skills:

Temperature Mapping & Controlled Temperature Units (CTUs) Part Washer & Autoclave Qualification HVAC System and Cleanroom Validation (ISO 7/8) Isolators, Biosafety Cabinets, and Laminar Airflow Systems Utilities Validation -

Compressed Air, Purified Water, Clean Steam Facility & Environmental Monitoring Systems Position Summary:

We are seeking an Equipment CQV Engineer to support qualification and validation activities for our client in Columbus, Ohio. The candidate will be responsible for executing temperature mapping studies, equipment qualifications, facility and/or utility system validation in compliance with ISO, cGMP, FDA, and internal quality standards.

Key Responsibilities:

Author, review, and execute Validation Protocols (IQ/OQ/PQ) for equipment and utilities in compliance with applicable cGMP and regulatory guidelines. Perform temperature mapping and qualification of Controlled Temperature Units (CTUs), including refrigerators, freezers, stability chambers, and warehouses. Support validation of facility and utility systems, including purified water, compressed air, HVAC, and clean steam systems. Oversee the qualification of process and cleaning equipment, including autoclaves, part washers, and sterilizers. Conduct risk assessments and determine a validation strategy in accordance with GAMP 5 and

ASTM E2500

principles. Collaborate cross-functionally with QA, Facilities, Manufacturing, and Engineering to ensure the timely completion of validation deliverables. Maintain traceability matrices, deviation logs, and validation summary reports. Participate in equipment change control and requalification activities. Ensure all validation documentation meets data integrity and GDP requirements.

Qualifications:

Bachelor's degree in Engineering, Life Sciences, or related field. Minimum 3 + years of experience in validation, equipment qualification, or facilities/utilities engineering in a GMP-regulated environment . Hands-on experience with temperature mapping, autoclaves, part washers, cleanroom qualification , and controlled temperature storage units. Familiarity with 21 CFR Part 11 , Annex 11 , and cGMP requirements. Strong understanding of GAMP 5 and

ASTM E2500

validation methodology. Excellent attention to detail, documentation, and communication skills.