Cleaning Validation Technical Specialist
4 weeks ago
Initially a 12 month contract.
ROLE: This role requires close collaboration with various departments and offers the opportunity to lead cleaning programs for Upstream and Downstream equipment.
Technical and operational knowledge of cleaning validation/verification of upstream and downstream equipment, quality systems and regulatory requirements across multiple health authorities.
Knowledge of downstream purification processes such as ultrafiltration is desirable.
Comprehensive understanding of c GMP requirements for biopharmaceutical manufacturing.
Good interpersonal skills coupled with proven ability to work effectively in a matrix organisation and in local group.
Ability to drive for results independently and adapt to rapidly evolving priorities.
Experience in cleaning validation and cleaning approaches to a multiproduct facility is advantageous.
Detail orientated and be proficient at technical writing.
Principal Responsibilities: Prepare and review relevant cleaning validation documentation including but not limited to protocols, reports, plans, risk assessments, technical/impact assessments.
Provide input on cleaning processes and troubleshoot/support cleaning activities related to both commercial operations and new product introduction.
Provide support for the technical services team during regulatory agency inspections.
Identify operational process improvements using Lean Tools.
Assist with the investigation of and operations deviations through the e QMS system, engaging with all relevant personnel and functions as appropriate.
Participating in technical projects, inclusive of process optimisation projects.
Responsibility for Change Management and Deviation Management.
Ability to manage competing priorities to ensure timely delivery of tasks.
Qualifications: Minimum of three years experience in cleaning validation, preferably in bulk drug substance manufacturing.
Experience in lean processing is an advantage.
Experience in preparation of routine documentation to GMP standard Experience working with digital tools and applications (MS Office, Adobe etc) Ability to read, comprehend and prepare applicable documentation required Skills: Cleaning Validation Technical Specialist Biopharmaceutical Lean Processing
-
Validation and Cleaning Specialist
3 days ago
Dublin, Dublin City, Ireland beBeeCleaning Full time €60,000 - €75,000Validation and Cleaning Specialist RoleWe are seeking an experienced Validation and Cleaning Specialist to join our team.Key Responsibilities:Develop, implement and manage qualification and validation documentation, including cycle development studies.Collaborate with production, maintenance and quality representatives on Cycle Development & Performance...
-
Cleaning Validation Specialist
2 weeks ago
Dublin, Dublin City, Ireland Tandem Project Management Limited Full timeSummary: Our client is a biopharmaceutical company based in Dublin looking for a Cleaning Validation Technical Specialist you will play a key role in supporting the cleaning validation activities for the c GMP manufacture of biological bulk drug substance (BDS) at their facility in Dublin.Responsibilities: Prepare and review relevant cleaning validation...
-
Validation Specialist Cleaning
1 week ago
Dublin, Dublin City, Ireland beBeeCleaning Full time €75,000 - €95,000Join Our Team As A Validation Specialist CleaningAbout The RoleWe are seeking a skilled and experienced Validation Specialist Cleaning to join our team. As a member of our validation team, you will be responsible for ensuring the accuracy and effectiveness of our cleaning processes.Key Responsibilities:Develop and implement cleaning validation...
-
Validation Specialist Cleaning
1 week ago
Dublin, Dublin City, Ireland MSD Malaysia Full timeValidation Specialist Cleaning page is loadedValidation Specialist CleaningApply remote type Hybrid locations IRL - Carlow - Carlow time type Full time posted on Posted 3 Days Ago time left to apply End Date: July 30, 2025 (11 days left to apply) job requisition id R356783Job DescriptionA new and exciting opportunity has come for a Validation Senior...
-
Senior Validation Specialist
1 week ago
Dublin, Dublin City, Ireland beBeeValidation Full timeWe are seeking a highly skilled Senior Validation Specialist to join our team. As a key member of the process engineering group, you will play a critical role in supporting the cleaning validation activities for the manufacture of biological bulk drug substance.The successful candidate will be responsible for developing and implementing cleaning strategies...
-
Validation Specialist Cleaning
1 week ago
Dublin, Dublin City, Ireland Merck Gruppe - MSD Sharp & Dohme Full timeJob DescriptionA new and exciting opportunity has come for a Validation Senior Engineering Specialist(s) on our Carlow Site with Technical Operations. You will be responsible for:Leadership of validation activities within the Recovery and Cleaning qualification team and across other validation teams.Maintaining compliance of Global Policies, Procedures and...
-
Cleaning Validation SME
3 weeks ago
Dublin, Dublin City, Ireland Tandem Project Management Limited Full timeSummary: We are currently seeking an experienced Cleaning Validation Specialist for our client, a biopharmaceutical company based in Dublin, to join a new project team on a short term contract to drive the development and implementation of a robust sampling and dispensing operation within their new facility. Responsibilities: Ensuring the highest standards...
-
Dublin, Dublin City, Ireland beBeeCleaning Full time €72,000 - €93,000Job Title:Cleaning Validation SpecialistAbout the RoleWe are seeking a skilled Cleaning Validation Specialist to support our cleaning validation activities for cGMP manufacture of biological bulk drug substance.The ideal candidate will provide expertise in developing and implementing cleaning strategies, optimising cleaning cycles, and leading execution of...
-
Cleaning Validation Sme
3 weeks ago
Dublin, Dublin City, Ireland Tandem Project Management Limited Full timeSummary: We are currently seeking an experienced Cleaning Validation Specialist for our client, a biopharmaceutical company based in Dublin, to join a new project team on a short term contract to drive the development and implementation of a robust sampling and dispensing operation within their new facility.Responsibilities: Ensuring the highest standards of...
-
Cleaning Validation SME
3 weeks ago
Dublin, Dublin City, Ireland Tandem Project Management Ltd. Full timeSummary: We are currently seeking an experienced Cleaning Validation Specialist for our client, a biopharmaceutical company based in Dublin, to join a new project team on a short term contract to drive the development and implementation of a robust sampling and dispensing operation within their new facility.Responsibilities:Ensuring the highest standards of...