Validation SpecialistApply Now Email Me Job ID SR0038290 Date posted 06/28/2019 Location: Neuchâtel, Switzerland
As Validation Specialist you will be responsible for planning, execution and reporting of validation tasks within the Engineering Validation department. The role responsibility covers creating, executing and enhancing facility, equipment, utility, cleaning, and sterilization 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, Technical Operations 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 manufacturing qualification activities. He/she performs a variety of activities to support CIP/SIP, Equipment and Process validation. 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 :
- Maintain and develop expertise in CIP/SIP, Equipment, MQ and Process Validation according to Takeda and Regulatory standards
- Write, review and approve Validation documents (validation protocols/reports, SOPs, RIAS, MVP...etc.) according to Takeda and Regulatory standards
- Participate in validation activities from strategy, planning, execution to validation reports
- Coordinate and follow-up validation protocols execution, ensuring that all validation activities and documents are completed and documented in a timely manner.
- Provide Validation expertise support related to strategy definition, problems solving, root cause analysis, CAPAs investigation and implementation steps
- 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 player 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
- Engineering degree or equivalent, preferably with biochemical or chemical background
- At least 5 years’ experience in the pharmaceutical/biotechnology industry
- 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)
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