Digital Manufacturing Validation Specialist

2 days ago

Dún Laoghaire, Dún Laoghaire-Rathdown, Ireland beBeeCompliance Full time €70,000 - €90,000

Job Description

Lead computer system validation activities for capital projects and deliver solutions that increase productivity and enable innovation.

  • Validate digital manufacturing projects, including automation, MES and real-time integration.
  • Develop CSV strategies and consistent approaches across capital projects.
  • Ensure compliance with Quality Management System, Systems Development Life Cycle, cybersecurity, and data integrity principles.
  • Act as subject-matter expert and primary liaison with product and technology teams.
  • Recruit, develop, and coordinate internal and external CSV resources.
  • Support development and maintenance of validation templates and standards.
  • Provide guidance, training, coaching, and ongoing validation support to project and site teams.
  • Coordinate with site compliance/validation, digital teams, quality functions, and other stakeholders to align activities.
  • Drive adoption of automation validation standards and validate automation systems and MES integrations.
  • Identify IT/OT compliance risks, lead remediation activities, and execute risk assessments.

Required Skills and Qualifications

  • Bachelor's degree in Computer Science, Engineering, Regulatory Compliance, or related field.
  • 8+ years supporting compliance and validation activities in capital projects.
  • Strong experience with systems used in digital manufacturing projects.
  • Deep knowledge of Systems Development Life Cycle (SDLC), Quality Management Systems, and computerized systems validation.
  • Familiarity with relevant regulations for computerized systems validation and compliance.
  • Working knowledge of ISA-95 and ISA-88 standards in a regulated environment.
  • Experience validating cloud, Software-as-a-Service, analytics, and data integration platforms.
  • Proven ability to design and implement validation plans and strategies.

Benefits

  • Work in a dynamic and collaborative environment.
  • Opportunities for professional growth and development.
  • Competitive compensation and benefits package.

Others

  • 25-35% travel requirement for assignments outside primary location.
  • Willingness to work independently and as part of a team.
  • Strategic thinker who can prioritize and deliver results.

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