Senior Validation Technicians

Hanley Calibration; Kerry Pike; On-site; EUR 55,000 - 75,000; Full time

Benefits offered by this job

Training & educational support systems

Employee Assistance Programme (EAP)

Pension Scheme

VHI Healthcare benefit allowance

Job summary

Hanley Calibration are currently hiring a Senior Validation Technician for aBlue Chip pharmaceutical site in Kerry. The role focuses on coordinating and executing validation activities, including IQ/OQ/PQ, temperature mapping, and document generation.

Collaboration with equipment owners ensures production schedules are not affected, with emphasis on continuous improvement and adherence to GMP standards. Educational requirements include a degree in Validation or Engineering, with over five years

Qualifications

• Strong commissioning experience and understanding of IQ/OQ/PQ and design processes.
• GMP experience in a pharmaceutical setting.
• Experience planning and executing schedules on CMMS systems.

Responsibilities

• Coordinate and manage the validation annual schedule to ensure activities are on time.
• Collaborate with equipment owners to avoid production disruption from validation activities.
• Schedule and perform temperature mapping and validation of equipment (refrigerators, freezers, cold rooms, etc.).
• Prepare and execute validation documents including protocols, summary reports, and lifecycle documents.

Skills

Commissioning experience

GMP experience

CMMS scheduling

Validation strategy

Problem solving

Education

Degree in Validation/Engineering

Tools

CMMS systems

Job description

Hanley Calibration are currently looking to hire Senior Validation Technicians for a Blue Chip pharmaceutical site in Kerry

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
• 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.
• Learns about customer's challenges, goals and drivers and articulates broad view on how Hanley Calibration can assist

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
• Fluent in English

Salary and Benefits

• Competitive Salary Package
• Training & educational support systems.
• Employee Assistance Programme (EAP).
• Pension Scheme
• VHI Healthcare benefit allowance