About this opportunity
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As part of the Validation team within Quality, the Validation Engineer will be responsible for the co-ordination, execution and reporting of Process, Transport and Cleaning Validation activities, along with supporting equipment/system/facility and utility qualifications
Key responsibilities will include, but are not limited to:
Responsible for the co-ordination, execution and reporting of Process, Transport and Cleaning Validation activities
Supporting equipment/system/facility/utility and laboratory qualification activities
Protocol preparation and Report writing.
Coordinate and report on cleaning monitoring, ongoing process verifications and equipment requalification activities ensuring that processes and equipment remain in a validated state
Execution of cleaning verification activities
Support Industrial Transfers, Internal Transfers and Optimisations
Assist in the preparation and carry out reviews of IQ / OQ / PQ documentation for the validation of equipments and systems
Responsible for Investigating and resolving non-conformances and deviations associated with validation studies.
Work closely with and co-ordinate the work of the persons responsible for validation in various departments and ensure the Company’s validation policies are respected.
Ensure all products/processes/equipment/systems are validated/qualified as per site procedures and policy.
Define the contents and ensure the control of validation documentation.
Adhere to the Change Management and Quality Management system procedures.
Ensure Registration compliance.
Support Root Cause Problem Solving and Risk Assessments.
Prepare, review and maintain SOP’s /Policies/Validation Master Plan detailing the company validation strategy.
Perform Training for Validation activity execution and implementation.
Contribute to achievement of the Validation Master Plan Project schedule and site KPI.
Keep up to date on current industry practices and regulatory expectations.
Support internal and external audit and inspections
Requirements for the position:
Minimum 2-3 years validation experience
A Third level degree in a Scientific or Engineering Discipline or equivalent.
A good knowledge of validation procedures and execution.
Pharmaceutical experience
Strong Communication and organisational skills
Experience in a GMP regulated environment
Good I.T. skills
Excellent Writing Skills
Whatever your area of expertise, your work within the Servier Group helps advance therapeutic progress for the benefit of patients. You will be part of teams recognized for their scientific excellence and reach your full potential in a professional environment that encourages you to develop yourself. Tailor-made onboarding journeys, mobility opportunities, quality trainings, responsible management, team spirit... All this and more in a workplace focused on your well-being.
At Servier, we are committed to therapeutic progress to serve patient needs. We put the diversity of our employees as a source of richness for the fulfillment of this vocation.
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