Validation & Engineering Group
ATL090425 CQV Specialist - Laboratory and Manufacturing Systems (NC)
Validation & Engineering Group, Greenville, North Carolina, United States, 27836
Job Description
Job Description
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 Bachelor’s 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.
Job Description
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 Bachelor’s 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.