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CSV Engineer

  • Job reference: 924846
  • Location: Dún Laoghaire, Dublin
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences
  • Date posted: 11/04/2019

Orion group are recruiting a CSV Engineer on behalf of our Multinational Biotechnology client based in Ireland - 12 month

Candidates must have at least 3 years' experience in:
- cGMP Regulated Environment
- computer system validation lifecycle
- working knowledge of GAMP software development lifecycle

See full details below:

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 and other regulatory requirements and standards.
* Assure that all validation test procedures are in line with current technology, corporate and governmental regulations.
* Ensure that the Validation Strategy meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards
* 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.
* Participate and communicate as required in project activities.
* Develop procedures to manage computerised systems where required
* Develop and present project plans to project management senior staff

Basic Qualifications:
* Bachelor of Science/Engineering degree or equivalent.
* Knowledge of cGMP's and other worldwide regulatory requirements.
* Problem solving ability and excellent oral and written communications skills
* Understanding of the computer system validation lifecycle

Preferred Qualifications
* 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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