Equipment Validator

21 hours ago

Cork, Cork, Ireland beBeeValidation Full time
Manufacturing Equipment Validation Specialist

Join our global team of experts to find the best talent for your business needs.

We are seeking an experienced Manufacturing Equipment Validation Specialist to work onsite in a dynamic environment. The role involves equipment validation related to technology transfer of existing processes from another site.

Key Responsibilities:
  • Perform qualification and validation of manufacturing, quality control, and supply chain equipment, including FAT, SAT, IQ, OQ, PQ, cleaning, temperature mapping, and sterilization.
  • Maintain validation programs to ensure Good Manufacturing Practice (GMP) compliance of manufacturing equipment, facilities, utilities, computer systems, and processes.
  • Conduct equipment design qualification and risk assessments to verify compliance with specifications and requirements.
  • Coordinate validation activities with manufacturing and quality control teams, analyzing results against acceptance criteria.
  • Collaborate with manufacturing, engineering, process support, supply chain, and quality to meet regulation and quality standards.
  • Prepare and review validation documentation, including Commissioning, Qualification, and Validation (CQV) protocols, calibration specifications, and out-of-tolerance records.
  • Manage quality system elements such as Change Controls, Deviations, and Investigations related to validation activities.
Required Skills and Qualifications:
  • Bachelor's degree in Engineering with 3-7 years of relevant experience or equivalent.
  • Experience with cGMPs and Good Engineering Practices.
  • Proven ability to manage multiple projects and work in cross-functional teams.
  • Knowledge of automation validation is preferred.
  • Experience with Quality Control equipment qualification is a plus.
Benefits:

This full-time position is located in Cork, Ireland, and falls under the Quality Assurance function within the Construction and Design Services industry.

Position type: Full-time

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