Senior Commissioning and Validation Specialist
1 semana atrás
Pharmaceutical companies seek highly motivated CQV Analysts to develop and execute commissioning, qualification, and validation protocols for new and existing equipment and processes.
Main Responsibilities:- Develop and implement commissioning, qualification, and validation strategies to ensure compliance with regulatory requirements.
- Conduct risk assessments and gap analyses to identify areas for improvement in quality and compliance.
- Perform equipment and process qualifications, including installation, operational, and performance qualifications.
- Review and approve validation documentation, including protocols, reports, and deviations.
- Collaborate with cross-functional teams to ensure compliance with regulatory requirements and company standards.
- Troubleshoot equipment and process issues and provide technical support to resolve them.
- Participate in audits and inspections, both internal and external, and assist with implementing corrective and preventative actions.
- Bachelor's degree in Engineering, Pharmacy, Chemistry, or a related field.
- Fluent in English and Portuguese.
- Minimum of 3 years experience in commissioning, qualification, and validation in the pharmaceutical industry.
- Strong knowledge of FDA and cGMP regulations.
- Experience with equipment and process validation, including IQ/OQ/PQ, cleaning validation, and process validation.
- Excellent problem-solving and analytical skills.
- Strong attention to detail and ability to work independently.
- Excellent communication and interpersonal skills.
- Ability to prioritize and manage multiple projects simultaneously.
-
Validation Specialist
Há 11 horas
São Paulo, São Paulo, Brasil beBeeValidation Tempo inteiro R$93.100 - R$121.110Our organization is seeking an experienced Validation Specialist to lead the validation of computer systems in medical devices applications. The successful candidate will be responsible for ensuring compliance with FDA guidelines and industry standards such as GAMP. About the Role:The Validation Lead will work closely with cross-functional teams to plan,...
-
Validation Specialist
2 semanas atrás
São Paulo, São Paulo, Brasil GWM Brasil Tempo inteiro**Validation Engineer Specialist****Job Mission**Ensure robust validation for new projects to Brazilian market, attending program needs and key project milestones.As a team, contribute to define and clarify the validation processes aligned with headquarters, generate engineering solutions, reports and develop team members.**Main Responsibilities**Define and...
-
São Paulo, São Paulo, Brasil beBeeAseptic Tempo inteiro R$4.000 - R$8.000Aseptic Equipment SpecialistThe ideal candidate will be responsible for the installation, start-up, commissioning and testing of aseptic equipment at customer sites. This includes providing technical assistance during and after the warranty period, conducting trainings, and other after-sales services.Key Responsibilities:Test and evaluate equipment...
-
Seasoned Commissioning Professional
Há 5 dias
São Paulo, São Paulo, Brasil beBeeWindFarmController Tempo inteiro €55 - €60Job OverviewWe are seeking a seasoned professional to lead the commissioning of wind farm controllers. This key role involves coordinating with clients, experts, and suppliers to deliver projects efficiently.Key Responsibilities:Commissioning of wind farm controller systems, including remote work.Testing and validation of grid code compliance for wind farm...
-
Electrical Commissioning Specialist
Há 4 dias
São Paulo, São Paulo, Brasil beBeeElectrical Tempo inteiro R$90.000 - R$120.000Electrical Commissioning ProfessionalWe are seeking a skilled Electrical Commissioning Engineer to join our team. As an Electrical Commissioning Professional, you will be responsible for planning, scheduling, coordinating, and executing full life cycle commissioning of critical facilities.The Role:Provide technical support to plan, schedule, coordinate, and...
-
Engineering Validation Specialist
Há 3 dias
São Paulo, São Paulo, Brasil beBeeValidation Tempo inteiro €50.000 - €80.000Engineering Validation Specialist OpportunityWe are seeking a skilled Validation Engineer to support various aspects of our validation process.Sterilization: Autoclaves, SIP of vesselsCleaning: Parts Washer and CIP of vesselsIsolator operations: Filling, Sterility & Material handlingThe ideal candidate will have experience in sterilization, cleaning, and...
-
Pharma Validation Engineer Ireland
1 semana atrás
São Paulo, São Paulo, Brasil PSC Biotech Corporation Tempo inteiroSenior Recruiter at PSC Biotech CorporationRole Description:Our site is excited to offer a fantastic Engineering Specialist (Validation) opportunity for candidates interested in a new challenge in a cGMP regulatory environment. The successful candidates will support several aspects of Validation. The roles available that will require experienced, energetic...
-
São Paulo, São Paulo, Brasil Cognizant Tempo inteiroSenior Virtual HIL Commissioning Engineer Join to apply for the Senior Virtual HIL Commissioning Engineer role at Cognizant Senior Virtual HIL Commissioning Engineer 1 day ago Be among the first 25 applicants Join to apply for the Senior Virtual HIL Commissioning Engineer role at Cognizant Who We AreCognizant (Nasdaq-100: CTSH) engineers' modern...
-
Equipment Specialist
Há 3 dias
São Paulo, São Paulo, Brasil beBeeValidation Tempo inteiro R$100.000 - R$150.000Commissioning, Qualification, and Validation AnalystThe Commissioning, Qualification, and Validation (CQV) Analyst is responsible for ensuring the compliance of equipment and processes within a regulated environment.Develop and execute commissioning, qualification, and validation protocols for new and existing equipment and processes.Conduct risk assessments...
-
Verification and Validation Specialist
1 dia atrás
São Paulo, São Paulo, Brasil beBeeValidation Tempo inteiro R$93.141 - R$131.569Verification and Validation ExpertWe are seeking a skilled professional to contribute to the development and implementation of Verification and Validation activities.Main Responsibilities:Develop verification methodologies for key deliverablesCreate test plans and descriptions for in-house tasksExecute and document test activitiesRepresent the organization...
