Validation Specialist
7 days ago
Job Role: Validation Specialist
Location: Ireland
Overview:
A skilled Validation Specialist is required to work with a pharmaceutical client based in Waterford. If you have experience in aseptic processing, lyophilisation, sterilisation and depyrogenation, this could be the perfect opportunity for you.
Key Responsibilities:
- Designing, executing and reporting on PV/Process Performance Qualifications.
- Designing, executing and reporting on validation studies for equipment, systems and processes.
- Providing technical interpretation and guidance of current US FDA and EU validation requirements for aseptic processing, lyophilisation, sterilisation and depyrogenation.
- Maintaining validation documentation through the validation lifecycle.
- Participation in external regulatory inspections and supporting Site Change Control processes.
- Capable of troubleshooting validation issues associated with projects, process development, etc.
Requirements:
- Degree in Science (Chemistry, Microbiology or Pharmacy preferred) or Engineering Chemical/Mechanical/Electrical.
- Previous validation/product development experience would be highly advantageous for the role.
- Knowledge of Process Validation regulations, current process validation and technical transfer industry practices, and experience with interpretation and application of guidelines and regulations.
- Knowledge of requirements for GAMP, ISPE Baseline guides.
- Knowledge of steam and dry heat validation publications such as AAMI/ANSI, PDA and ISO guidelines.
- Full understanding of relevant quality and compliance regulations.
- Able to execute projects to plan.
- Good knowledge of quality management systems.
- Good communication skills at organisation, team and individual levels.
- Ability to use MS Project and SPC packages (an advantage).
-
Validation Specialist
2 weeks ago
Waterford, Waterford, Ireland beBeeValidation Full time €70,000 - €90,000Job Title: Senior Validation SpecialistOur company is seeking a highly skilled and experienced Senior Validation Specialist to join our team. As a key member of our validation department, you will be responsible for ensuring the compliance of our equipment and systems with regulatory requirements.Lead and Support Validation ActivitiesDevelop and Execute...
-
Validation Specialist
2 weeks ago
Waterford, Waterford, Ireland beBeevalidation Full time €60,000 - €90,000Job Title:">Validation Specialist">OverviewOur client is a leading pharmaceutical company seeking a Validation Specialist to join their team. As a key member of the validation team, you will be responsible for designing, executing, and reporting on process validation/Process Performance Qualifications (PVs) and equipment validation...
-
Validation Specialist
2 weeks ago
Waterford, Waterford, Ireland beBeeValidation Full time €70,000 - €90,000Job Overview">A Validation Specialist is required to lead our pharmaceutical client's project. This 12-month contract offers a unique opportunity for a skilled professional in aseptic processing, lyophilisation, sterilisation, and depyrogenation.Key ResponsibilitiesDeveloping and executing process performance qualifications and validation studies for...
-
Validation Specialist
6 days ago
Waterford, Waterford, Ireland beBeeValidation Full time €45,000 - €60,000Job Title: Validation SpecialistThe primary focus of this role is to develop and implement validation strategies for various equipment, systems, and processes within the quality management framework.Key Responsibilities:Design and execute validation plans, protocols, and reports in compliance with regulatory requirements.Collaborate with cross-functional...
-
Process Validation Specialist
7 days ago
Waterford, Waterford, Ireland beBeeValidation Full time €58,000 - €86,000Process Validation Specialist RoleThe Process Validation Specialist is responsible for ensuring that all manufacturing processes are validated to meet regulatory requirements.Key Responsibilities:Design and execute process validation studies for equipment, systems, and processes.Develop and maintain validation documentation throughout the validation...
-
System Validation Specialist
2 weeks ago
Waterford, Waterford, Ireland beBeeCompliance Full time €60,000 - €90,000Validator Compliance SpecialistWe are seeking a skilled specialist to play a key role in ensuring the ongoing validation compliance of computerised equipment and systems in a sterile manufacturing environment.The ideal candidate will have a strong background in computer systems validation, with experience working in a healthcare manufacturing...
-
CSV Validation Specialist
2 weeks ago
Waterford, Waterford, Ireland beBeePharmaceutical Full time €60,000 - €90,000CSV Validation SpecialistCatalyx is seeking a CSV validation specialist to work in a manufacturing environment.The RoleLead and support validation activities for new and existing computerised equipment and control systems.Generate validation documentation (protocols/reports) and assist with the execution of validation protocols.Participate in the change...
-
Process Validation Specialist
2 weeks ago
Waterford, Waterford, Ireland beBeevalidation Full time €68,000 - €82,000Process Validation Specialist About the Role: We are seeking a skilled Process Validation Specialist to join our team. In this role, you will be responsible for executing FAT/SAT/IOQ protocols, designing and reporting on validation studies, and ensuring compliance with regulatory requirements. Key Responsibilities: Develop and execute validation protocols...
-
Data Validation Specialist
2 weeks ago
Waterford, Waterford, Ireland beBeeValidation Full time €80,000 - €120,000Looking for a new role where engineering meets impact? This Data Validation Specialist role is calling your name.We are seeking a highly skilled professional to support the validation and compliance of computerized equipment and systems in a sterile pharmaceutical manufacturing environment. This role involves hands-on validation activities, ensuring...
-
Data Validation Specialist
1 week ago
Waterford, Waterford, Ireland beBeeValidation Full time €40,000 - €80,000Job SummaryWe are seeking a skilled Data Validation Specialist to join our team. As a CSV Engineer, you will be responsible for ensuring the validation and compliance of computerized equipment and systems in sterile pharmaceutical manufacturing environments.Key Responsibilities:Develop and execute validation protocols (DQ, IQ, OQ, PQ) for computerized...
