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CSV Engineer

  • Job reference: 930172
  • Location: Dublin South, Dublin
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Engineering, Manufacturing & Facilities, Life Sciences
  • Date posted: 21/02/2020

Orion Group Life Sciences are looking for a CSV Engineer for our Multinational Pharmaceutical client based in the South of Dublin area on an initial 12-month contract with the potential to extend.


Job Purpose

As a member of the Information Systems team, the individual will act as an IS Tech Writer and will support complex and challenging initiatives across the full breadth of Information Systems.


Main Responsibilities of 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 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

Desired Experience and Background of the successful candidate
* 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
* Candidates must have at least 5 years' experience in:
- cGMP Regulated Environment
- Computer system validation lifecycle
- Working knowledge of GAMP software development lifecycle


#pharmaceutical #pharma #multinational #product #CSV #IT #validation

For more information on this role, call George McGlone on +353 (0) 212063414 or email George.McGlone@orioneng.com for a completely confidential chat about this role and other opportunities using the reference number: 930172


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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