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.
Essential Duties & Responsibilities
* Write, review and approve Validation documents (validation protocols/reports, SOPs, RIAS, MVP...etc.) according to the Regulatory standards
* Provide Validation expertise support related to strategy definition, problems solving, root cause analysis, CAPAs investigation and implementation steps
* Maintain and develop expertise in CIP/SIP, Equipment, MQ and Process Validation according to the Regulatory standards
* Participate in validation activities from strategy, planning, execution to validation reports
* Participate in internal or external audits, as required. Follow-up on audit observations topics and ensure closure on time
Coordinate and follow-up validation protocols execution, ensuring that all validation activities and documents are completed and documented in a timely manner.
* Demonstrated interpersonal and expertise skills with ability to interface well with other departments, and lead effectively and efficiently validation engineering topics
* Must have uncompromising dedication to quality and an excellent understanding of cGMPs and other regulatory guidelines
* Ability to manage multiple priorities in a manufacturing plant setting
* Ability to analyze, review and interpret engineering validation data
* 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.
French B1 and English B1
Michael Bailey International is acting as an Employment Business in relation to this vacancy.