Job DescriptionJob DescriptionValidation & 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:AVS / Environmental Monitoring Performance Qualification (EMPQ) - Validation OwnerDevelop Risk Assessment (RA)Evaluate project change control and confirm EM PQ scope of work.Generate Validation Plan (VP).Develop and execute EM PQ protocols.AVS document development, execution and post approvals.Develop EM PQ reports for applicable systems.Pursue project deliverables.Qualifications:Bachelor's Degree in Science or Engineering.Minimum of 5 years of experience in direct pharmaceutical, medical device or biotechnology industries.Must be fully bilingual (English / Spanish) with excellent oral skills.Strong knowledge in cGxP and regulatory guidance.Solid experience performing AVS / Environmental Monitoring Performance Qualification (EMPQ)Sampling Plan strategy and data analysis of results.Experience with Commissioning, Qualification and Validation (CQV)Solid experience in the development of Risk Assessments (RA)Practical knowledge developing and executing Computer System Life Cycle (SDLC) documents. i.e. VP, URS, FDS, RA, IOPQ, TMX, and ReportsTechnical Writing skills and investigations processes.Available to work extended hours, possibility of weekends and holidays.
Job DescriptionJob DescriptionValidation & 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:AVS / Environmental Monitoring Performance Qualification (EMPQ) - Validation OwnerDevelop Risk Assessment (RA)Evaluate project change control and confirm EM PQ scope of work.Generate Validation Plan (VP).Develop and execute EM PQ protocols.AVS document development, execution and post approvals.Develop EM PQ reports for applicable systems.Pursue project deliverables.Qualifications:Bachelor's Degree in Science or Engineering.Minimum of 5 years of experience in direct pharmaceutical, medical device or biotechnology industries.Must be fully bilingual (English / Spanish) with excellent oral skills.Strong knowledge in cGxP and regulatory guidance.Solid experience performing AVS / Environmental Monitoring Performance Qualification (EMPQ)Sampling Plan strategy and data analysis of results.Experience with Commissioning, Qualification and Validation (CQV)Solid experience in the development of Risk Assessments (RA)Practical knowledge developing and executing Computer System Life Cycle (SDLC) documents. i.e. VP, URS, FDS, RA, IOPQ, TMX, and ReportsTechnical Writing skills and investigations processes.Available to work extended hours, possibility of weekends and holidays.
Job DescriptionJob DescriptionValidation & 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:AVS / Environmental Monitoring Performance Qualification (EMPQ) - Validation OwnerDevelop Risk Assessment (RA)Evaluate project change control and confirm EM PQ scope of work.Generate Validation Plan (VP).Develop and execute EM PQ protocols.AVS document development, execution and post approvals.Develop EM PQ reports for applicable systems.Pursue project deliverables.Qualifications:Bachelor's Degree in Science or Engineering.Minimum of 5 years of experience in direct pharmaceutical, medical device or biotechnology industries.Must be fully bilingual (English / Spanish) with excellent oral skills.Strong knowledge in cGxP and regulatory guidance.Solid experience performing AVS / Environmental Monitoring Performance Qualification (EMPQ)Sampling Plan strategy and data analysis of results.Experience with Commissioning, Qualification and Validation (CQV)Solid experience in the development of Risk Assessments (RA)Practical knowledge developing and executing Computer System Life Cycle (SDLC) documents. i.e. VP, URS, FDS, RA, IOPQ, TMX, and ReportsTechnical Writing skills and investigations processes.Available to work extended hours, possibility of weekends and holidays.
Job DescriptionJob DescriptionValidation & 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:AVS / Environmental Monitoring Performance Qualification (EMPQ) - Validation OwnerDevelop Risk Assessment (RA)Evaluate project change control and confirm EM PQ scope of work.Generate Validation Plan (VP).Develop and execute EM PQ protocols.AVS document development, execution and post approvals.Develop EM PQ reports for applicable systems.Pursue project deliverables.Qualifications:Bachelor's Degree in Science or Engineering.Minimum of 5 years of experience in direct pharmaceutical, medical device or biotechnology industries.Must be fully bilingual (English / Spanish) with excellent oral skills.Strong knowledge in cGxP and regulatory guidance.Solid experience performing AVS / Environmental Monitoring Performance Qualification (EMPQ)Sampling Plan strategy and data analysis of results.Experience with Commissioning, Qualification and Validation (CQV)Solid experience in the development of Risk Assessments (RA)Practical knowledge developing and executing Computer System Life Cycle (SDLC) documents. i.e. VP, URS, FDS, RA, IOPQ, TMX, and ReportsTechnical Writing skills and investigations processes.Available to work extended hours, possibility of weekends and holidays.
Job DescriptionJob DescriptionValidation & 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:Environmental Monitoring Performance Qualification (EMPQ) - Sr CQV ScientistEvaluate project change control and confirm EM PQ scope of work.Generate Validation Plan (VP).Develop and execute EM PQ protocols.Develop EM PQ reports for applicable systems.Pursue project deliverables.Qualifications:Bachelor's Degree in Science or Engineering.Minimum of 5 years of experience in direct pharmaceutical, medical device or biotechnology industries.Must be fully bilingual (English / Spanish) with excellent oral skills.Strong knowledge in cGxP and regulatory guidance.Solid experience performing Environmental Monitoring Performance Qualification (EMPQ).Sampling Plan strategy and data analysis of resultsExperience with Commissioning, Qualification and Validation (CQV).Solid experience in the development of Risk Assessments.Practical knowledge developing and executing Computer System Life Cycle (SDLC) documents. i.e. VP, URS, FDS, RA, IOPQ, TMX, and Reports.Technical Writing skills and investigations processes.Available to work extended hours, possibility of weekends and holidays.
Job DescriptionJob DescriptionValidation & 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:Environmental Monitoring Performance Qualification (EMPQ) - Sr CQV ScientistEvaluate project change control and confirm EM PQ scope of work.Generate Validation Plan (VP).Develop and execute EM PQ protocols.Develop EM PQ reports for applicable systems.Pursue project deliverables.Qualifications:Bachelor's Degree in Science or Engineering.Minimum of 5 years of experience in direct pharmaceutical, medical device or biotechnology industries.Must be fully bilingual (English / Spanish) with excellent oral skills.Strong knowledge in cGxP and regulatory guidance.Solid experience performing Environmental Monitoring Performance Qualification (EMPQ).Sampling Plan strategy and data analysis of resultsExperience with Commissioning, Qualification and Validation (CQV).Solid experience in the development of Risk Assessments.Practical knowledge developing and executing Computer System Life Cycle (SDLC) documents. i.e. VP, URS, FDS, RA, IOPQ, TMX, and Reports.Technical Writing skills and investigations processes.Available to work extended hours, possibility of weekends and holidays.
Job DescriptionJob DescriptionValidation & 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:Environmental Monitoring Performance Qualification (EMPQ) - Sr CQV ScientistEvaluate project change control and confirm EM PQ scope of work.Generate Validation Plan (VP).Develop and execute EM PQ protocols.Develop EM PQ reports for applicable systems.Pursue project deliverables.Qualifications:Bachelor's Degree in Science or Engineering.Minimum of 5 years of experience in direct pharmaceutical, medical device or biotechnology industries.Must be fully bilingual (English / Spanish) with excellent oral skills.Strong knowledge in cGxP and regulatory guidance.Solid experience performing Environmental Monitoring Performance Qualification (EMPQ).Sampling Plan strategy and data analysis of resultsExperience with Commissioning, Qualification and Validation (CQV).Solid experience in the development of Risk Assessments.Practical knowledge developing and executing Computer System Life Cycle (SDLC) documents. i.e. VP, URS, FDS, RA, IOPQ, TMX, and Reports.Technical Writing skills and investigations processes.Available to work extended hours, possibility of weekends and holidays.
Job DescriptionJob DescriptionValidation & 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:Environmental Monitoring Performance Qualification (EMPQ) - Sr CQV ScientistEvaluate project change control and confirm EM PQ scope of work.Generate Validation Plan (VP).Develop and execute EM PQ protocols.Develop EM PQ reports for applicable systems.Pursue project deliverables.Qualifications:Bachelor's Degree in Science or Engineering.Minimum of 5 years of experience in direct pharmaceutical, medical device or biotechnology industries.Must be fully bilingual (English / Spanish) with excellent oral skills.Strong knowledge in cGxP and regulatory guidance.Solid experience performing Environmental Monitoring Performance Qualification (EMPQ).Sampling Plan strategy and data analysis of resultsExperience with Commissioning, Qualification and Validation (CQV).Solid experience in the development of Risk Assessments.Practical knowledge developing and executing Computer System Life Cycle (SDLC) documents. i.e. VP, URS, FDS, RA, IOPQ, TMX, and Reports.Technical Writing skills and investigations processes.Available to work extended hours, possibility of weekends and holidays.
Job DescriptionJob DescriptionValidation & 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:Environmental, Health & Safety SpecialistRole: 100% On Site
MUST HAVE:
They must have knowledge in analysis and generation of risks and mitigations. Also, OSHA 1910 and OSHA 1926 application knowledge.
Summary/Overview of this role:
Responsible and accountable for the implementation of the environmental, health and safety programs that achieve compliance with applicable local/federal regulations and result in an environmentally safe workplace. Support contractor safety program to ensure that all contractors adhere to company safety standards and regulatory requirements.
DUTIES & RESPONSIBILITIESConduct safety orientations and training sessions for contractors before they begin work on-site.Monitor contractor activities to ensure compliance with safety protocols and address any safety concerns promptly.Review and approve contractor safety plans and risk assessments.Maintain records of contractor safety performance and incidents.Develop and maintain quarterly compliance metrics to track the effectiveness of safety programs and identify areas for improvement.Collect and analyze safety data, including incident reports, inspection findings, and training records.Prepare and present quarterly safety performance reports to management, highlighting key metrics and trends.Advise management on the proper procedures, work practices, equipment to use in order to ensure compliance with all legal requirement and legal requirements and regulations in these fields.Implements, audits compliance programs to ensure compliance with applicable local, federal regulations, company programs/standards.Provide assistance and support on environment, health and safety related issues. Implements policies and procedures that promote an environmental and healthy workplace and minimize the safety and environmental impact on operations.Offer training programs to meet the environmental, health and safety needs. Participate in process hazard reviews of new and existing equipment to ensure environmental, industrial hygiene and safety issues are addressed.Participate in emergency response team activities and trainings to ensure facility is prepared in the event of an emergency.Assists in facilitation and department EHS self-inspections.Participates in incident investigations related with environment, industrial hygiene and safety to determine causes and develop action plan to avoid recurrence. Follow-up to ensure improvements are made.Actively participate in Local Emergency Planning Committee.Keep abreast of current technologies and maintains appropriate certifications.Maintains a safe work environment. Performs other related duties, as required.Education:
Associate's degree in Occupational Health and Safety, Environmental Science, or a related field. A bachelor's degree is preferred.
Experience Required:
Three (3) years experience in a manufacturing environment.
MINIMUM REQUIREMENTS:Knowledge of applicable OSHA and PROSHA local and Federal Regulations and Corporate Requirements.Knowledge of emergency response procedures and technical overall operations.Self-starter, analytical and administrative skills.Ability to communicate and work effectively in a team oriented environment.Knowledge of cGMP’sGood investigative skills.Working knowledge of Personal Computer (MS Word, Excel and Power Point).Fully bilingual (English/Spanish).Effective verbal and written communications skills.Ability to design training curriculum and to develop/deliver effective regulatory training in EHS.Ability to complex mathematical calculation for sample analysis.Ability to establish and maintain excellent working relationship with a variety of internal and external customers.Ability to plan work schedules and set priorities with urgency and meet deadlines within a complex, rapidly changing environment.Strong organizational skills.Flexible and responsible.
Job DescriptionJob DescriptionValidation & 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:Environmental, Health & Safety SpecialistRole: 100% On Site
MUST HAVE:
They must have knowledge in analysis and generation of risks and mitigations. Also, OSHA 1910 and OSHA 1926 application knowledge.
Summary/Overview of this role:
Responsible and accountable for the implementation of the environmental, health and safety programs that achieve compliance with applicable local/federal regulations and result in an environmentally safe workplace. Support contractor safety program to ensure that all contractors adhere to company safety standards and regulatory requirements.
DUTIES & RESPONSIBILITIESConduct safety orientations and training sessions for contractors before they begin work on-site.Monitor contractor activities to ensure compliance with safety protocols and address any safety concerns promptly.Review and approve contractor safety plans and risk assessments.Maintain records of contractor safety performance and incidents.Develop and maintain quarterly compliance metrics to track the effectiveness of safety programs and identify areas for improvement.Collect and analyze safety data, including incident reports, inspection findings, and training records.Prepare and present quarterly safety performance reports to management, highlighting key metrics and trends.Advise management on the proper procedures, work practices, equipment to use in order to ensure compliance with all legal requirement and legal requirements and regulations in these fields.Implements, audits compliance programs to ensure compliance with applicable local, federal regulations, company programs/standards.Provide assistance and support on environment, health and safety related issues. Implements policies and procedures that promote an environmental and healthy workplace and minimize the safety and environmental impact on operations.Offer training programs to meet the environmental, health and safety needs. Participate in process hazard reviews of new and existing equipment to ensure environmental, industrial hygiene and safety issues are addressed.Participate in emergency response team activities and trainings to ensure facility is prepared in the event of an emergency.Assists in facilitation and department EHS self-inspections.Participates in incident investigations related with environment, industrial hygiene and safety to determine causes and develop action plan to avoid recurrence. Follow-up to ensure improvements are made.Actively participate in Local Emergency Planning Committee.Keep abreast of current technologies and maintains appropriate certifications.Maintains a safe work environment. Performs other related duties, as required.Education:
Associate's degree in Occupational Health and Safety, Environmental Science, or a related field. A bachelor's degree is preferred.
Experience Required:
Three (3) years experience in a manufacturing environment.
MINIMUM REQUIREMENTS:Knowledge of applicable OSHA and PROSHA local and Federal Regulations and Corporate Requirements.Knowledge of emergency response procedures and technical overall operations.Self-starter, analytical and administrative skills.Ability to communicate and work effectively in a team oriented environment.Knowledge of cGMP’sGood investigative skills.Working knowledge of Personal Computer (MS Word, Excel and Power Point).Fully bilingual (English/Spanish).Effective verbal and written communications skills.Ability to design training curriculum and to develop/deliver effective regulatory training in EHS.Ability to complex mathematical calculation for sample analysis.Ability to establish and maintain excellent working relationship with a variety of internal and external customers.Ability to plan work schedules and set priorities with urgency and meet deadlines within a complex, rapidly changing environment.Strong organizational skills.Flexible and responsible.