Mantell Associates is partnered with a leading Biotech organisation in their search for a Process Validation Expert to lead and support Process Performance Qualification (Process Validation) activities in accordance with Regulatory requirements.

Process Validation Expert - Responsibilities:

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• Develop pre-validation / validation strategy, including the strategy for supportive studies

• Coordinate activities between all departments involved in individual activities of drug substance manufacturing process validation and cleaning validation

• Create protocols and validation reports

• Initiate monitoring and continuous process verification phase and compilation of the first APQR

• Act as single point of contact for a given validation process

• Contribute to the overall strategy and plans of projects scope, including the creation of schedules and budgets

• Develop validation plans, scientifically sound technical strategies (with validation team) and contingency plans, identifying obstacles and proposing possible solutions

• Planning of resource needs (full time, investment, external costs), strategies and schedules

• Form and lead a validation team, setting team priorities and meetings, coordinating team activities, ensuring compliance with guidelines, EHS and GMP guidelines

• Supervise updating documentation and / or project tracking tools as planned

• Develop the main validation documentation (eg: protocol, report). Support the production of the master batch report and documents related to the validation of the DS manufacturing process

• Review and coordinate the delivery of input data to key documents and registrations for accuracy and completeness (where applicable)

• Participate in preparations for and in the inspections of pharmaceutical regulatory authorities

• Coordinate the preparations for the production campaign (as part of the validation of the active substance manufacturing process)

• Participate in the development and updating of procedures and documentation templates as part of validation of manufacturing processes

• Contribute to the optimisation of DS manufacturing validation processes

• Inform direct supervisor about all abnormalities in process, documentation, progress of tasks and decisions

• Report the work progress and tasks status to supervisor, as well as preparation of performed tasks

Process Validation Expert - Requirements:

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• Higher education in the field: biotechnology, pharmacy or related

• Strong professional experience in the biotechnology or pharmaceutical/medical industry

• Experience in validation of manufacturing processes and cleaning validation

• Excellent knowledge of GMP, EMA and FDA requirements and current technology transfer guidelines

• The ability to organise work well and to cooperate in a team

• Ability to identify and solve problems independently

• Very good knowledge of MS Office

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Mantell Associatesis a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +44 (0)20 3854 7700.