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