Senior Validation Engineer
Opportunity for a Senior Validation Engineer to work with a highly renound technical services company within a multinational biopharmaceuticals companies limerick base.
Requirements
Strong Commissioning Experience.
Good understanding of the IQ, OQ, PQ and Design Process.
GMP Experience in Pharmaceutical background.
Strong experience in planning and executing schedules on CMMS systems.
Co-ordinating and managing the validation annual schedule to ensure that validation activities are performed on time.
Collaborating with equipment owners to ensure that validation activities do not impact production schedule.
Regular interaction with customer management, attending all recommended meetings on client schedule and equipment.
Scheduling and Performing temperature mapping and validation of equipment such as Refrigerators, Freezers, Cold Rooms, Warehouses, Stability Chambers, Cryogenic Freezers, and Incubators.
Execute validation documentation including protocols, summary reports, procedures, other lifecycle documents using computer systems such as EDMS, BMRAM and Valgenesis.
Ability to identify the appropriate Commissioning and Qualification strategy to apply on a specific project and define the list of actives requires to ensure the on time completion of a large scale project.
Ability to generate, review and follow up on IQ, OQ, PQ documentation from start to finish in order to align with the relevant GMP and CQV requirements.
Continuous Improvement of process and machine reliability to achieve the highest level of plant reliability.
Work as part of the work centre team to support the area.
Developing and implementing new ideas, modifications and techniques leading to improvements to processes.
Maintaining housekeeping in the engineering workshops and associated working areas.
Train others / Apprentices / Contractors on line changeovers and line adjustment to agreed standards.
Good Problem Solving skills
Good Scheduling preparation, review and implementation skills
Ability to manage and coordinate other contractors and vendors
Takes pride in delivery of a quality service.
Takes personal accountability, ownership and action to do the right thing.
Educational Requirements
Degree or Equivalent in an Validation or Engineering Role Discipline or Time served in an Electrical and Instrumentation (E& I) role with experience in Validation
>5 years' experience in the Pharmaceutical industry
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