Validation Specialist _ CSV/IT
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Validation Specialist _ CSV/ITApply Now
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Job Posting Title: Validation Specialist _ CSV/IT
As Validation Specialist you will be responsible for planning, execution and reporting of validation tasks within the Engineering Services department. The role responsibility covers definition of validation strategy, creating, executing and enhancing CSV/IT validation activities for the site.
As Validation Specialist you will have an active involvement in continues improvement, development and implementation of new initiatives. You will assure issue resolution arising from validation activities in cooperation with Quality, Automation, process Engineering and Manufacturing (e.g. deviation handling, CAPA and change requests).
The role is expected to have a solid understanding of industry standards and validation compliance requirements and is required to supply support/technical knowledge for the development/refinement and implementation of validation standards.
The Validation Specialist performs, troubleshoots and supports the qualification activities of manufacturing equipment. He/she performs a variety of activities to support CSV/IT and C&Q. He/she represents the validation on project teams and interfaces with peers in various other departments such as engineering and manufacturing to ensure that design, implementation and qualification processes are conducted according to established quality standards.
Essential Duties & Responsibilities:
- Support the preparation of projects documents, such as: URS, RIAS, FS process, FD, P&IDs, traceability Matrix,
- Provide Validation Expertise to support evaluation of:, protocol deviations, CAPA, Change control, solving problems/root cause in case of routine and project issues.
- Define validation strategy according to Takeda and regulatory standards.
- Maintain and develop expertise in CSV/IT and CQV activities according to Takeda and Regulatory standards
- Write, review and approve Validation documents (RIAS, VPP, validation protocols/reports, SOPs…etc.) according to Takeda and Regulatory standards
- Coordinate and follow-up validation protocols execution, ensuring that all validation activities and documents are completed and documented in a timely manner.
- Participate in internal or external audits, as required. Follow-up on audit observations topics and ensure closure on time
- We are looking for a strong energetic team member with good communication skills,
- Demonstrated interpersonal and expertise skills with ability to interface well with other departments, and lead effectively and efficiently validation engineering topics
- Ability to manage multiple priorities in a manufacturing plant setting
- Ability to analyze, review and interpret engineering validation data
- Must have uncompromising dedication to quality and an excellent understanding of cGMPs and other regulatory guidelines
- Interpersonal skills that enables you to work with people at all levels
- Ability to plan, multitask, and manage time effectively
- Must display personal accountability for results and integrity
- Must display eagerness to learn, to innovate, drive for solutions and continuously improvement
- Knowledges in cleaning and sterilization validation would be appreciated
- Engineering degree or equivalent
- At least 5 years’ experience in the pharmaceutical/biotechnology industry with CSV/IT background (relevant IT System such as MES,ERP..etc.)
- cGMP and validation skills
- Broad validation knowledge, industrial trends and validation related literature
- Solid computer skills including Word, Excel, PowerPoint.
- Very good English level (oral and written)
- Very good French level (oral and written)
LocationsCHE - Neuchatel
Time TypeFull time
Job ID R0030063