Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
CQV Specialist – Media Fill (Aseptic Process)
Overview
The Media Fill CQV Specialist is responsible for planning, executing, and documenting aseptic process simulations to ensure sterility assurance across filling operations. This role supports validation of operational practices, interventions, and equipment configurations in compliance with FDA, EMA, and Annex 1 requirements.
Key Responsibilities
Plan and execute Media Fill (Aseptic Process Simulation) studies in coordination with QA, Manufacturing, and Aseptic Operations.
Verify proper execution of interventions, sampling plans, and line configurations.
Ensure media fill setup aligns with aseptic processing requirements, including operator practices, equipment state, and environmental conditions.
Monitor contamination control strategies and document all observations.
Prepare protocols (APS Plans, PQ protocols), execute testing, and draft final reports.
Manage deviations, CAPAs, investigations, and risk assessments associated with media fills.
Support regulatory audit readiness and provide technical justification during inspections.
Ensure compliance with FDA Aseptic Processing Guidance, EU Annex 1, and 21 CFR 210/211.
Maintain data integrity and GMP documentation standards (ALCOA+).
Required QualificationsBachelor’s in Life Sciences, Microbiology, Engineering, or related discipline.
5+ years of experience in aseptic operations, process validation, or APQ/CQV.
Strong understanding of aseptic techniques, cleanroom behavior, and contamination control.
Experience writing and executing validation protocols (PQ, APS).
Ability to analyze results, perform root cause investigations, and justify decisions to QA and regulators.
Preferred SkillsExperience in fill-finish or parenteral manufacturing.
Knowledge of isolators, RABS, and automated filling systems.
Familiarity with EM programs and ISO 14698.
Read LessValidation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
CQV Specialist – Smoke Testing / Airflow VisualizationOverviewThe CQV Specialist for Smoke Testing is responsible for developing, executing, and documenting airflow visualization studies in support of cleanroom and equipment qualification. This role verifies unidirectional airflow, identifies turbulence zones, and ensures compliance with Annex 1 airflow requirements for sterile manufacturing.
Key ResponsibilitiesPlan and execute smoke studies (airflow visualization) for cleanrooms, RABS, isolators, filling lines, and critical Grade A/B environments.
Set up and qualify smoke/fog generation equipment, lighting, and video recording systems.
Document airflow patterns to identify turbulence, dead spots, reverse flows, and compliance gaps.
Support qualification activities including FAT/SAT, IQ/OQ, and room qualification for HVAC systems.
Write protocols (airflow visualization plans, IQ/OQ protocols) and prepare final reports with photographic/video evidence.
Interface with Engineering, Facilities, QA, and Aseptic Operations to resolve airflow issues.
Lead deviations, risk assessments, and CAPAs related to airflow or equipment performance.
Ensure compliance with ISO 14644-1/2, EU Annex 1 airflow requirements, and ASTM E2500.
Support regulatory inspection readiness and provide airflow-related technical responses.
Required QualificationsBachelor’s in Mechanical Engineering, Industrial Engineering, Life Sciences, or related field.
5+ years of experience in CQV, HVAC qualification, or aseptic facility commissioning.
Strong understanding of airflow dynamics, HEPA performance, differential pressure control, and cleanroom classification.
Experience with IQ/OQ execution for cleanroom equipment, isolators, and RABS.
Ability to interpret airflow patterns and provide engineering recommendations.
Preferred SkillsExperience with particle counters, differential pressure monitoring, BMS/EMS systems.
Experience qualifying sterile filling lines or aseptic equipment.
Knowledge of HVAC balancing, cleanroom design, and environmental controls.
Read LessValidation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
Project Manager for Capital ProjectsQualifications:
Bachelor's Degree in Science or Engineering.Minimum of 5 years of experience in direct pharmaceutical, medical device or biotechnology industries.Solid experience in Capital Project ManagementEquipment URSInstallations coordinationManage the integration of equipment delivery and installation, tie-ins, commissioning, SAT, PMs, Calibration, Qualification processes and TOPKnowledge of Cost ControlMust be fully bilingual (English / Spanish) with excellent oral skills.Strong knowledge in cGxP and regulatory guidanceKnowledge of Commissioning, Qualification and Validation documents and exercisesTechnical Writing skills and investigations processes.Available to work extended hours, possibility of weekends and holidays. Read LessValidation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
C&Q/CSV Validation Scientist - Utilities/HVAC/FacilitiesQualifications:
Bachelor’s degree in science.Minimum of 3 years of experience in the Life Science Industry.Experience in Equipment, Facilities, HVAC, Utilities and Process Qualification.( i.e:Dust Collectors and Cyclone Units, Compressed Air, HVAC, Facility (Room, Paging System, Access Control and Fire System) Knowledge in Computer Systems.Technical Writing experience.Industry Practices (cGMP, GDP, GEP, etc.)Must be fully bilingual (English / Spanish) with excellent oral skills.Experience with developing and executing Qualification Documents such as VP, URS, RA, DQ, TMX, IOPQ with CSV.Available to work extended hours, possibility of weekends and holidays. Read LessValidation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
C&Q/CSV Validation Scientist - Utilities/HVAC/FacilitiesQualifications:
Bachelor’s degree in science.Minimum of 3 years of experience in the Life Science Industry.Experience in Equipment, Facilities, HVAC, Utilities and Process Qualification.( i.e:Dust Collectors and Cyclone Units, Compressed Air, HVAC, Facility (Room, Paging System, Access Control and Fire System) Knowledge in Computer Systems.Technical Writing experience.Industry Practices (cGMP, GDP, GEP, etc.)Must be fully bilingual (English / Spanish) with excellent oral skills.Experience with developing and executing Qualification Documents such as VP, URS, RA, DQ, TMX, IOPQ with CSV.Available to work extended hours, possibility of weekends and holidays. Read LessValidation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
C&Q/CSV Validation Scientist - Utilities/HVAC/FacilitiesQualifications:
Bachelor’s degree in science.Minimum of 3 years of experience in the Life Science Industry.Experience in Equipment, Facilities, HVAC, Utilities and Process Qualification.( i.e:Dust Collectors and Cyclone Units, Compressed Air, HVAC, Facility (Room, Paging System, Access Control and Fire System) Knowledge in Computer Systems.Technical Writing experience.Industry Practices (cGMP, GDP, GEP, etc.)Must be fully bilingual (English / Spanish) with excellent oral skills.Experience with developing and executing Qualification Documents such as VP, URS, RA, DQ, TMX, IOPQ with CSV.Available to work extended hours, possibility of weekends and holidays. Read LessValidation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
C&Q/CSV Validation Scientist - Utilities/HVAC/FacilitiesQualifications:
Bachelor’s degree in science.Minimum of 3 years of experience in the Life Science Industry.Experience in Equipment, Facilities, HVAC, Utilities and Process Qualification.( i.e:Dust Collectors and Cyclone Units, Compressed Air, HVAC, Facility (Room, Paging System, Access Control and Fire System) Knowledge in Computer Systems.Technical Writing experience.Industry Practices (cGMP, GDP, GEP, etc.)Must be fully bilingual (English / Spanish) with excellent oral skills.Experience with developing and executing Qualification Documents such as VP, URS, RA, DQ, TMX, IOPQ with CSV.Available to work extended hours, possibility of weekends and holidays. Read LessValidation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
C&Q/CSV Validation Scientist - Utilities/HVAC/FacilitiesQualifications:
Bachelor’s degree in science.Minimum of 3 years of experience in the Life Science Industry.Experience in Equipment, Facilities, HVAC, Utilities and Process Qualification.( i.e:Dust Collectors and Cyclone Units, Compressed Air, HVAC, Facility (Room, Paging System, Access Control and Fire System) Knowledge in Computer Systems.Technical Writing experience.Industry Practices (cGMP, GDP, GEP, etc.)Must be fully bilingual (English / Spanish) with excellent oral skills.Experience with developing and executing Qualification Documents such as VP, URS, RA, DQ, TMX, IOPQ with CSV.Available to work extended hours, possibility of weekends and holidays. Read LessValidation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
C&Q/CSV Validation Scientist - Utilities/HVAC/FacilitiesQualifications:
Bachelor’s degree in science.Minimum of 3 years of experience in the Life Science Industry.Experience in Equipment, Facilities, HVAC, Utilities and Process Qualification.( i.e:Dust Collectors and Cyclone Units, Compressed Air, HVAC, Facility (Room, Paging System, Access Control and Fire System) Knowledge in Computer Systems.Technical Writing experience.Industry Practices (cGMP, GDP, GEP, etc.)Must be fully bilingual (English / Spanish) with excellent oral skills.Experience with developing and executing Qualification Documents such as VP, URS, RA, DQ, TMX, IOPQ with CSV.Available to work extended hours, possibility of weekends and holidays. Read LessValidation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
C&Q/CSV Validation Scientist - Utilities/HVAC/FacilitiesQualifications:
Bachelor’s degree in science.Minimum of 3 years of experience in the Life Science Industry.Experience in Equipment, Facilities, HVAC, Utilities and Process Qualification.( i.e:Dust Collectors and Cyclone Units, Compressed Air, HVAC, Facility (Room, Paging System, Access Control and Fire System) Knowledge in Computer Systems.Technical Writing experience.Industry Practices (cGMP, GDP, GEP, etc.)Must be fully bilingual (English / Spanish) with excellent oral skills.Experience with developing and executing Qualification Documents such as VP, URS, RA, DQ, TMX, IOPQ with CSV.Available to work extended hours, possibility of weekends and holidays. Read Less