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CSV Engineer

  • Job reference: 920970
  • Location: Dublin South, Dublin
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Engineering, Manufacturing & Facilities, Life Sciences
  • Date posted: 03/08/2018

The Orion Group are seeking a CSV Engineer to work with our multinational Pharmaceutical client in Dublin.

The role is an initial 12 month contract role with an immediate start.

The Role:

  • Development of Validation Plans, Installation Qualifications (IQs), Operational Qualifications (OQs) and Summary Reports.
  • Prepare, execute, document and report validation protocols in line with GMP's
  • Review and Approve validation protocols and assessments from a quality system documentation perspective.
  • Liaise with Engineering / Automation and external vendors regarding equipment documentation, HDS, SDS, FDS, User Requirement Specifications (URS's), and any other associated validation issues.

Requirements:

  • Candidates must have at least 3 years' experience in cGMP Regulated Environment
  • Computer system validation lifecycle experience and working knowledge of GAMP software development lifecycle
  • Bachelor of Science/Engineering degree or equivalent.
  • Knowledge of cGMP's and other worldwide regulatory requirements.
  • Candidates must have demonstrated experience in the delivery and management of IS / Automation systems in addition to a working knowledge of GAMP software development lifecycle, ANSI/ISA-S88 industry standards.
  • The successful candidate will have a least 3 years' experience validating IS Automation systems for manufacturing organizations in the biotechnology or pharmaceutical industries.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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