ATL090425 CQV Specialist � Laboratory and Manufacturing Systems (NC)

Validation & Engineering Group Inc. (V&EG) is a leading technical services provider specializing in high-quality Commissioning & Qualification Validation Compliance Quality Assurance and Engineering services for the Biotechnology Pharmaceutical Advanced Therapies Medical Device and Chemical (API) industries.

We are seeking a talented dedicated individual committed to working under the highest ethical standards for the following position:

• Laboratory and Manufacturing SystemsCQV Specialist

Position Overview
We are seeking an experienced Validation & Qualification Specialist to support laboratory equipment commissioning qualification and validation projects within a biotechnology / FDA-regulated environment. While the primary focus will be on laboratory systems the individual will also provide support as needed to C&Q activities related to aseptic filling lyophilization packaging and conveyor systems.

Responsibilities

• Author execute and review validation protocols (IQ OQ PQ) for laboratory equipment and systems in compliance with cGMP FDA EMA and site standards.

• Perform commissioning and qualification activities for instruments such as HPLCs Zetasizers tensile testers particle counters titrators plate readers incubators refrigerators and freezers.

• Conduct temperature mapping/distribution studies and support the qualification of controlled temperature environments.

• Support validation of computerized systems and laboratory management systems in alignment with 21 CFR Part 11 and EU Annex 11.

• Participate in FAT/SAT and qualification of aseptic manufacturing equipment and related utilities as needed.

• Perform risk assessments discrepancy resolution root cause investigations and support change control/CAPA activities.

• Prepare and review technical documentation including protocols reports and risk assessments to ensure audit readiness.

• Provide project status updates and collaborate cross-functionally to achieve timely equipment release and compliance.

• Contribute to continuous improvement by streamlining validation workflows and strengthening site quality culture.

Qualifications

• Bachelors degree in engineering life sciences or a related field.

• Minimum 3 years of experience in validation and qualification within pharmaceutical biotech or FDA-regulated environments.

• Proficiency in laboratory equipment qualification (e.g. HPLC ZwickRoelle Instron Zetasizer Maurice CE-SDS HIAC titrators genetic analyzers mapping systems).

• Experience with IQ/OQ/PQ FAT/SAT risk assessments and validation protocol/report generation.

• Strong understanding of regulatory requirements including cGMP 21 CFR Part 11 EU Annex 11 ICH guidelines and data integrity principles.

• Demonstrated ability to manage deviations discrepancies and CAPAs.

• Excellent organizational and technical writing skills with the ability to work effectively in a project environment.

• Bilingual in English and Spanish preferred.

Preferred Qualifications

• Experience supporting aseptic operations (filling lyophilization packaging conveyors).

• Familiarity with validation software tools and quality systems such as TrackWise.

• Previous involvement in laboratory equipment relocation or international qualification projects.