Current jobs related to Process Validation Expert - Cork, Cork - Life Science Recruitment
-
Cork, Cork, Ireland beBee Careers Full timeMain ResponsibilitiesDesign and Execute Validation Studies: Develop, execute, and report on Process Performance Qualifications (PV) and validation studies for equipment, systems, and processes.Ensure Regulatory Compliance: Verify that validation studies meet all required standards and legal requirements, including cGMP, Health & Safety, environmental...
-
Validation Expert
1 week ago
Cork, Cork, Ireland beBee Careers Full timeJob DescriptionWe are seeking a highly skilled Validation Expert to join our team.The successful candidate will be responsible for defining and implementing procedures and processes to ensure the quality of our facilities, equipment, and supporting systems.This includes documenting evidence that these systems can perform effectively and reproducibly to meet...
-
Process Validation Expert
2 weeks ago
Cork, Cork, Ireland beBee Careers Full timeAbout the RoleA skilled Process Validation Engineer is required to execute, review and approve validation activities in a GMP regulated environment.This is an hourly rate contract position with excellent opportunities for growth and development.The successful candidate will be responsible for:Proficiently handling process validation requirements for new...
-
Process Validation Expert
2 days ago
Cork, Cork, Ireland beBee Careers Full timeProcess Validation EngineerThis is an exciting opportunity to work in a state-of-the-art facility.Perform process validation activities related to drug substance and drug products, through defined clinical and commercial stages.Execute process validation activities related to the implementation of process changes and new processes while exercising supervised...
-
Process Validation Expert
5 days ago
Cork, Cork, Ireland beBee Careers Full timeAbout the JobThe Validation Engineer will play a key part in maintaining regulatory compliance and ensuring that our client's products meet the highest standards. This involves owning and supporting validation activities, as well as participating in change control processes.Key ResponsibilitiesOwn and support validation activities.Responsible for all Process...
-
Process Validation Expert
2 weeks ago
Cork, Cork, Ireland beBee Careers Full timeThis position requires a highly skilled and motivated individual to lead validation efforts and ensure compliance with regulatory requirements. You will be responsible for developing and implementing validation and qualification policies, procedures, and protocols, and ensuring the quality and compliance of our products.Your responsibilities will include...
-
Validation and Process Specialist
2 weeks ago
Cork, Cork, Ireland beBee Careers Full timeJob DescriptionWe are seeking an experienced Process Validation Expert to join our team. As a key member of our manufacturing operations, you will be responsible for providing technical support for existing processes and aspects of the development, commercialization, and technology transfer of new processes into the operations/manufacturing environment.
-
Validation Expert
2 weeks ago
Cork, Cork, Ireland beBee Careers Full timeJob SummaryA Validation Expert is needed to own and support validation activities in a Medical Device regulated environment.Key Responsibilities:Support validation activities.Execute Process Validation's as per CDRH Guidance.Implement Software Validation Executions.Conduct Resolution of Problems encountered during validation.Develop Consistency in...
-
Process & Validation Scientist
3 weeks ago
Cork, Cork, Ireland TN Ireland Full timeJob DescriptionPROCESS AND VALIDATION SCIENTIST with an understanding of key TS/MS deliverables such as Tech Transfer, Process Monitoring, Process Validation, On-going Process Verification and Annual Product Reviews required by CareerWise Recruitment for our multinational Biotechnology client in Co. Cork, this is a permanent role. The PROCESS AND VALIDATION...
-
Process & Validation Scientist
2 weeks ago
Cork, Cork, Ireland CareerWise Recruitment Full timeJob Description PROCESS AND VALIDATION SCIENTIST with an understanding of key TS/MS deliverables such as Tech Transfer, Process Monitoring, Process Validation, On-going Process Verification and Annual Product Reviews required by CareerWise Recruitment for our multinational Biotechnology client in Co. Cork, this is a permanent role. The PROCESS AND...
Process Validation Expert
2 weeks ago
We are recruiting for an exciting opportunity with a leading Medical Device organization in Limerick.
About the RoleThis is an excellent position for individuals who want to join a multinational that excels in their industry.
- Competent in process validation requirements on new manufacturing processes, equipment introductions & process changes.
- Responsible for performing process validation (OQ & PQ) by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements.
You will utilize six sigma statistical analysis and experimental design tools to characterize processes and support process validation activities. Additionally, you will write, execute, and review all validation documents. You will define the requirements for Process Validation in alignment with approved SOPs and execute test plans according to approved procedures.
Your responsibilities will include tabulating test results, organizing data packages, compiling and analyzing data, preparing reports, and making recommendations for changes and/or improvements. You may also investigate and troubleshoot problems which occur and determine solutions.
You will coordinate and execute validation change control and preparation of protocols and reports. You will participate on cross-functional project teams with the support of Development, Manufacturing, Engineering, Quality, and other groups.
In addition, you will prepare summaries of validation testing for regulatory submissions and present validations to regulatory agencies. You will independently apply validation principles to work assignments, review and approve documents, and resolve problems.
You will also coordinate assigned projects and represent department on project teams. Furthermore, you will resolve validation issues of moderate scope with limited direct supervision.
Requirements- Degree qualified in a relevant Engineering / Science discipline, with 5+ years relevant experience.
- Extensive understanding and application of validation principles, concepts, practices, and standards particularly in relation to Process Validation.
- Six Sigma Black Belt certified is preferred.
- Experience in Statistical analysis & experimental design is essential.
