Qualification & Validation Specialist
5 days ago
Qualification & Validation Specialist Location : Waterford Duration : 12+ months Our Team: In the Validation Engineer role, you will be required to support new product introductions, equipment qualification and the site requalification program. The Validation Engineer has a key role in ensuring the on-going validation and compliance of existing and new equipment, systems and processes. The following activities will be included as part of your role. Main responsibilities: The following activities will be included as part of your role: Designing, executing and reporting on PV/Process Performance Qualifications. Designing, executing and reporting on validation studies for equipment, systems and processes. Ensuring validation studies are managed in conjunction with all required standards and legal requirements (Health & Safety, cGMP, construction, environmental etc.) Providing technical interpretation and guidance of current US FDA and EU validation requirements for aseptic processing, lyophilisation, sterilisation and depyrogenation Ensuring that the validation status of equipment and systems are in compliance with cGMP at all times Maintaining validation documentation through the validation lifecycle Participation in external regulatory inspections Support Site Change Control process Technical skills: Capable of troubleshooting validation issues associated with projects, process development etc. Competent technical knowledge of pharmaceutical plants. 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 of interpretation and application of guidelines and regulations. Knowledge of requirements for of 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 Understands KPIs for the site. Candidates should hold appropriate RTWs for Ireland i.e. Stamp1G, Stamp 4, Irish/British/EU passport. For more information please apply here or contactAgnes Reena/Contact: eir evo talent is an equal opportunity employer who seeks to recruit and appoint the best available person for a job regardless of marital / civil partnership status, sex (including pregnancy), age, religion, belief, race, nationality and ethnic or national origin, colour, sexual orientation or disability. eir evo talent apply all relevant Data Protection laws when processing your Personal Data. If you choose to apply to this opportunity and share your CV or other personal information with eir evo talent, these details will be held by us in accordance with our privacy policy used by our recruitment team to contact you regarding this or other relevant opportunities at eir evo talent. Ref:ITC5615 Candidates must be eligible to work full time and long term in the location specified or currently hold a valid appropriate long term work Visa to apply. eir evo talent, eir evo and our clients are equal opportunity employers who seeks to recruit and appoint the best available person for a job regardless of marital / civil partnership status, sex (including pregnancy), age, religion, belief, race, nationality and ethnic or national origin, colour, sexual orientation or disability. eir evo talent, eir evo and our clients apply all relevant Data Protection laws when processing your Personal Data. If you choose to apply to this opportunity and share your CV or other personal information with eir evo talent, eir evo and our clients, these details will be held by us in accordance with our privacy policy used by our recruitment team to contact you regarding this or other relevant opportunities at eir evo talent and eir evo Skills: GAMP Process Validation cGMP Benefits: Work From Home
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Qualification & Validation Specialist
2 days ago
Waterford, Waterford, Ireland TN Ireland Full timeSocial network you want to login/join with:Qualification & Validation Specialist, WaterfordClient:ProclinicalLocation:Waterford, IrelandJob Category:OtherEU work permit required:YesJob Reference:8995a228ed2dJob Views:2Posted:02.04.2025Expiry Date:17.05.2025Job Description:Proclinical is seeking a Qualification & Validation Specialist to focus on ensuring...
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Qualification & Validation Specialist
2 days ago
Waterford, Waterford, Ireland Proclinical Staffing Full timeProclinical is seeking a Qualification & Validation Specialist to focus on ensuring that equipment and processes meet required standards and regulations. Initially, you will work full-time on-site to build connections and receive training, transitioning to a hybrid model thereafter.Please note that to be considered for this role you must have the right to...
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Qualification & Validation Specialist
6 days ago
Waterford, Ireland Proclinical Full timeProclinical is seeking a Qualification & Validation Specialist to focus on ensuring that equipment and processes meet required standards and regulations. Initially, you will work full-time on-site to build connections and receive training, transitioning to a hybrid model thereafter. Please note that to be considered for this role you must have the right to...
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Qualification & Validation Specialist
6 days ago
Waterford, Waterford, Ireland Proclinical Full timeProclinical is seeking a Qualification & Validation Specialist to focus on ensuring that equipment and processes meet required standards and regulations. Initially, you will work full-time on-site to build connections and receive training, transitioning to a hybrid model thereafter. Please note that to be considered for this role you must have the right to...
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Qualification & Validation Specialist
2 days ago
Waterford, Waterford, Ireland Proclinical Group Full timeProclinical is seeking a Qualification & Validation Specialist to focus on ensuring that equipment and processes meet required standards and regulations. Initially, you will work full-time on-site to build connections and receive training, transitioning to a hybrid model thereafter.Please note that to be considered for this role you must have the right to...
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Qualification & Validation Specialist
2 days ago
Waterford, Waterford, Ireland Eirevo Full timeQualification & Validation SpecialistLocation: WaterfordDuration: 12+ monthsOur Team:In the Validation Engineer role, you will be required to support new product introductions, equipment qualification, and the site requalification program. The Validation Engineer has a key role in ensuring the ongoing validation and compliance of existing and new equipment,...
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Qualification & Validation Specialist
2 days ago
Waterford, Waterford, Ireland Eir evo talent Full timeQualification & Validation SpecialistLocation: WaterfordDuration: 12+ monthsOur Team:In the Validation Engineer role, you will be required to support new product introductions, equipment qualification, and the site requalification program. The Validation Engineer has a key role in ensuring the ongoing validation and compliance of existing and new equipment,...
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Qualification & Validation Specialist
2 days ago
Waterford, Waterford, Ireland Prochem Engineering Full timeSenior Recruitment Specialist at Prochem EngineeringIn this Validation Engineer role, you will be required to support new product introductions, equipment qualification and the site requalification program. The Validation Engineer has a key role in ensuring the on-going validation and compliance of existing and new equipment, systems and processes. The...
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Qualification & Validation Expert
2 days ago
Waterford, Waterford, Ireland Proclinical Staffing Full timeAt Proclinical Staffing, we are seeking a highly skilled Qualification & Validation Expert to join our team. In this role, you will play a critical part in ensuring that equipment and processes meet required standards and regulations.Your primary focus will be on developing and executing qualification and validation protocols for equipment and processes,...
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Qualification Specialist
2 days ago
Waterford, Waterford, Ireland Eirevo Full timeJob Description:">Company OverviewEirevo is a leading company in the industry, dedicated to providing high-quality services to our clients.We are seeking an experienced Qualification & Validation Specialist to join our team.Job ResponsibilitiesThe successful candidate will be responsible for designing, executing, and reporting on PV/Process Performance...
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Senior Qualification Specialist
2 days ago
Waterford, Waterford, Ireland Eir evo talent Full timeAbout the RoleThis is an exciting opportunity to join our team as a Validation Engineer. In this role, you will be responsible for supporting new product introductions, equipment qualification, and site requalification programs.Your Key Responsibilities will include:Designing, executing, and reporting on PV/Process Performance Qualifications.Designing,...
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Pharmaceutical Validation Specialist
1 day ago
Waterford, Waterford, Ireland Recruitment by Aphex Group Full timeAt Recruitment by Aphex Group, we are seeking a highly motivated Pharmaceutical Validation Specialist to join our team.Job DescriptionThis role will be responsible for supporting new product introductions, equipment qualification, and the site requalification program. As a key member of the team, you will ensure ongoing validation and compliance of existing...
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Qualification and Compliance Specialist
4 days ago
Waterford, Waterford, Ireland Hibernia Services Limited Full timeAbout the RoleThis position plays a key role in ensuring the validation status of equipment and systems complies with cGMP at all times. The Validation Engineer will participate in designing, executing, and reporting on validation studies for equipment, systems, and processes.Main Responsibilities:Executing PV/Process Performance Qualifications and...
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Qualification and Compliance Expert
5 days ago
Waterford, Waterford, Ireland Hibernia Services Limited Full timeJob Summary: Hibernia Services Limited is seeking a highly experienced GAMP Process Validation Specialist to join our team. As a GAMP Process Validation Specialist, you will play a key role in ensuring the validation and compliance of our equipment, systems, and processes.Main Responsibilities:Maintaining validation documentation through the validation...
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Validation and Compliance Specialist
2 days ago
Waterford, Waterford, Ireland Proclinical Group Full timeThe Proclinical Group is hiring a Validation and Compliance Specialist to focus on ensuring equipment and processes meet industry standards and regulations.You will initially work full-time on-site to build connections and receive training, transitioning to a hybrid model thereafter.About the Role:Design and execute validation protocols for equipment and...
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Only 24h Left Qualification
6 days ago
Waterford, Waterford, Ireland Hibernia Services Limited Full timeQualification & Validation Specialist Location : Waterford Duration : 12+ months Our Team: In the Validation Engineer role, you will be required to support new product introductions, equipment qualification and the site requalification program. The Validation Engineer has a key role in ensuring the on-going validation and compliance of existing and new...
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Pharmaceutical Validation Specialist
6 days ago
Waterford, Waterford, Ireland TN Ireland Full timeJob DescriptionA Pharmaceutical Validation Specialist is required for a 12 month contracting position at our client's Waterford site. This role involves the validation of new equipment, processes, and control systems.Key ResponsibilitiesDevelop and execute DQ, IQ, OQ, and PQ activities to ensure compliance with cGMP.Provide technical assistance on current US...
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Equipment Qualification Manager
2 days ago
Waterford, Waterford, Ireland Proclinical Group Full timeProclinical Group is looking for an Equipment Qualification Manager to oversee the development and execution of qualification protocols for equipment and processes.In this role, you will work closely with cross-functional teams to ensure compliance with industry standards and regulatory requirements.About the Position:Develop and maintain comprehensive...
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Validation and Compliance Specialist
2 days ago
Waterford, Waterford, Ireland Prochem Engineering Full timeKey ResponsibilitiesDesigning and Executing PV/Process Performance Qualifications: Develop and execute plans for qualifying equipment and processes to ensure compliance with cGMP regulations.Validation Studies: Design, execute and report on validation studies for equipment, systems and processes to ensure they meet company standards and regulatory...
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Process Qualification Expert
1 day ago
Waterford, Waterford, Ireland Recruitment by Aphex Group Full timeWe are looking for a skilled Process Qualification Expert to join our team at Recruitment by Aphex Group.About the RoleYou will play a critical role in ensuring the ongoing validation and compliance of existing and new equipment, systems, and processes within our organisation.Responsibilities:Develop and execute qualification protocols for equipment and...
