Cleaning Validation Specialist
2 days ago
CLEANING VALIDATION SPECIALIST
Job Purpose:
Pfizer Grange Castle seeks a Cleaning Validation Specialist to work within the Cleaning Validation Team supporting new product introduction and cleaning validation activities across the site.
A critical enabler to product manufacture is a robust, and audit ready cleaning validation program that allows the plant to operate at full capacity and complete product changeover in a safe and efficient manner.
This is an ideal development opportunity to join a dynamic team who provide cleaning validation support to the manufacturing areas and support process transfer and new product introduction projects into the manufacturing facilities.
The cleaning validation specialist is responsible for providing technical support for cleaning validation activities and strategies for equipment used in manufacture of drug substances and drug products in accordance with regulatory requirements and company manufacturing standards.
The role focuses on cleaning validation execution, cleaning validation design, cleaning monitoring and troubleshooting, including leading and resolving technical issues and manufacturing investigation relating to cleaning processes, support new product introductions, facility design and equipment design specifications.
The role will provide the opportunity to develop technical, communication and project management skills through interaction and collaboration with multiple departments (Operations, Quality, Engineering) that support the site cleaning validation program. The role may entail specialisation and training in process science/engineering to meet overall site business needs for technical support.
Job Responsibilities:
1. This is a non-laboratory based role supporting the site cleaning validation program.
2. Generate, review and approve documentation for cleaning validation including protocols, summary reports, validation plans, and supporting documents.
3. Cleaning validation execution, including cleaning monitoring.
4. Generate, review and approve validation deviations and ensure successful implementation of corrective actions.
5. Write impact assessments in support of investigation closures.
6. Provide expertise for trouble shooting and resolution of problems.
7. Co-operate with multifunctional team to deliver projects on time.
8. Support bench scale studies such as cleaning efficacy, recovery studies, solubility.
9. Develop and maintain cleaning validation strategies including product and equipment grouping strategies.
10. Develop and maintain cleaning acceptance criteria for manufacturing equipment.
11. Identify and drive continuous improvements within the group to ensure streamlined and efficient Cleaning Validation.
12. Technology transfer for new processes and new product introduction.
13. Regulatory inspection support and close-out of regulatory follow-up measures.
14. Technology transfer of new processes or process changes.
Skills:
1. A minimum of 2 years cGMP industrial experience with good technical writing skills.
2. Minimum 12 months of Cleaning Validation experience.
3. Demonstrated aptitude for technical learning and problem solving.
4. Continuous improvement mindset to drive positive change.
5. Proactive, persistent, and good communication skills.
Education:
Third level qualification in Science or Engineering is required. Exceptions may be considered where relevant skills/experience and correct attitude and behaviours exist (this may be supplemented by further education in parallel).
#J-18808-Ljbffr
-
Cleaning Validation Specialist
2 weeks ago
Dublin, Dublin City, Ireland Quanta Consultancy Services Ltd Full timeCleaning Validation Specialist - Pharmaceuticals - 12 Month Contract - DublinAre you looking for the chance to join a life-changing pharmaceutical organisation in their mission to continuously drive innovation? We are recruiting for a Cleaning Validation Specialist for a 12-month contract based in Dublin.Located 15 minutes from Dublin Airport and just a...
-
Cleaning Validation Specialist
3 weeks ago
Dublin, Dublin City, Ireland Quanta Consultancy Services Ltd Full timeCleaning Validation Specialist - Pharmaceuticals - 12 Month Contract - DublinAre you looking for the chance to join a life-changing pharmaceutical organisation in their mission to continuously drive innovation? We are recruiting for a Cleaning Validation Specialist for a 12-month contract based in Dublin.Located 15 minutes from Dublin Airport and just a...
-
Cleaning Validation Specialist
2 weeks ago
Dublin, Dublin City, Ireland Quanta part of QCS Staffing Full timeCleaning Validation Specialist - Pharmaceuticals - 12 Month Contract - Dublin Are you looking for the chance to join a life changing pharmaceutical organisation in their mission to continuously drive innovation? We are recruiting for a Cleaning Validation Specialist for a 12-month contract based in Dublin. Located 15 minutes from Dublin Airport and...
-
Cleaning Validation Specialist
2 weeks ago
Dublin, Dublin City, Ireland Life Science Recruitment Full timeWe're currently recruiting for an exciting opportunity with a Pharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.DutiesExecute cleaning cycle development and PQ of equipment.Writing and adhering to validation strategies, coordinating with...
-
Dublin, Dublin City, Ireland CPL Full timeCpl in partnership with our client Pfizer are seeking a Cleaning Validation Specialist to join the team for an 11 month Fixed term Contingent contract at their state of the art plant in Dublin Grange Castle. CLEANING VALIDATION SPECIALISTJob Purpose:Pfizer Grange Castle seeks a Cleaning Validation Specialist to work within the Cleaning Validation Team...
-
Validation Engineer
2 weeks ago
Dublin, Dublin City, Ireland VALIDATION ASSOCIATES LLC Full timeThe ultimate purpose of technology teams in GxP environments is to serve the evolving needs of the business. We are a specialist provider of consultancy and implementation services for IT infrastructure and data architectures within life science manufacturing. Our role is to be a companion on the road for technology teams to be able to use as a tool at times...
-
Validation Specialist
2 weeks ago
Dublin, Dublin City, Ireland TN Ireland Full timeSocial network you want to login/join with:Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.We are PCI.Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.Main...
-
Cleaning Validation Engineer
2 days ago
Dublin, Dublin City, Ireland Life Science Recruitment Full timeCleaning Validation EngineerAMC19711 month contractCarlowI am currently on the look out for a Cleaning Validation Engineer for a Biopharmaceutical manufacturing plant in Carlow. This is the perfect role for someone with Cleaning validation experience looking for their next contract.Responsibilities:Ensure that site cleaning practices adhere to external...
-
Validation Specialist
2 weeks ago
Dublin, Dublin City, Ireland Viatris Inc. Full timeAt VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.Viatris empowers people worldwide to live healthier at every stage of life.We do so via:1. Access – Providing high quality trusted medicines regardless of geography or...
-
QA Validation Specialist
2 weeks ago
Dublin, Dublin City, Ireland Cpl Healthcare Full timeCpl in partnership with our client Pfizer are Seeking a QA Validation Specialist to join the team at their state of the art Dublin, Grange Castle Plant for an 11 month fixed term contract with Hybrid working model.Role:To provide a compliance overview of sitewide validation activities. To provide technical QA support to the Engineering function (including...
-
Validation and Tech Transfer Specialist
1 day ago
Dublin, Dublin City, Ireland LSC, Life Science Consultants Full timeValidation and Tech Transfer Specialist (BBBH27990) Dublin, Republic of IrelandThe Validation & Tech Transfer Specialist will be responsible for developing and maintaining validation (process and cleaning validation, continued process verification) and tech transfer guidance and supporting toolkit to support implementation in a consistent manner across...
-
QA Systems and Validation Specialist
2 weeks ago
Dublin, Dublin City, Ireland Cpl Healthcare Full timeQA Systems and Validation Specialist(12 month Contract)Location: Swords CampusABOUT USSK biotek Ireland, an SK pharmteco company, is a global Contract Development and Manufacturing organisation (CDMO) with state-of-the-art facilities in Korea, US, France and Ireland. We are part of the wider SK Inc. with revenues of $95 billion in 2020. Our mission is to...
-
Validation Specialist
3 weeks ago
Dublin, Dublin City, Ireland Viatris Inc. Full timeTransforming Healthcare for a Better WorldViatris empowers people worldwide to live healthier at every stage of life.Our Mission and ValuesAccess – Providing high-quality trusted medicines regardless of geography or circumstance;Leadership – Advancing sustainable operations and innovative solutions to improve patient health;Partnership – Leveraging our...
-
Validation Specialist
1 day ago
Dublin, Dublin City, Ireland Life Science Recruitment Full timeExciting Opportunity with a Pharmaceutical OrganizationWe're currently recruiting for an exciting opportunity with a Pharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.DutiesExecute cleaning cycle development and PQ of equipment.Writing...
-
QA Systems and Validation Specialist New
2 weeks ago
Dublin, Dublin City, Ireland CPL Full timeQA Systems and Validation Specialist(12 month Contract)Location: Swords Campus,ABOUT US?SK biotek Ireland, an SK pharmteco company, is a global Contract Development and Manufacturing organisation (CDMO) with state-of-the-art facilities in Korea, US, France and Ireland. We are part of the wider SK Inc. with revenues of $95 billion in 2020. Our mission is to...
-
QA Validation Specialist
2 days ago
Dublin, Dublin City, Ireland Hobson Prior Full timeHobson Prior is collaborating with a Biotech company who are in search of a Specialist in QA Validation. The chosen individual will offer supervision for the production and distribution of Gene Therapy medicinal products. They will be instrumental in guaranteeing that processes and equipment meet validation and qualification standards as per relevant...
-
Validation Engineer
2 days ago
Dublin, Dublin City, Ireland MSD Malaysia Full timetime left to apply End Date: March 29, 2025 (18 days left to apply)job requisition id R337503Job DescriptionOur Carlow 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 candidate will support Cleaning Validation including...
-
QA Validation Specialist New 2/8/2025 A
1 week ago
Dublin, Dublin City, Ireland CPL Full timeCpl in partnership with our client Pfizer are Seeking a QA Validation Specialist to join the team at their state of the art Dublin, Grange Castle Plant for an 11 month fixed term contract with Hybrid working model. Role:To provide a compliance overview of sitewide validation activities. To provide technical QA support to the Engineering function (including...
-
QA Systems and Validation Specialist
2 weeks ago
Dublin, Dublin City, Ireland DPS Group Global Full timePosition Description:The QA Systems and Validation Specialist will be responsible for:Assessment of changes for GMP compliance in accordance with site change control procedure for facilities, utilities, lab and manufacturing equipment and control system changes.Review and approve the GMP design aspects of major capital projects including new facility...
-
Validation Specialist
1 week ago
Dublin, Dublin City, Ireland West Pharmaceutical Services Full timeWho We Are: At West, we're a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of...
