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Process Validation Engineer

  • Job reference: 925270
  • Location: Limerick
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Engineering, Manufacturing & Facilities, Life Sciences
  • Date posted: 03/05/2019

Orion Group are recruiting a Process Validation Engineer on behalf of one of our Multinational Medical Device Clients on an initial 12 month contract based in Limerick.

Description:

Position Description and Responsibilities

  • The Process Validation engineer will be responsible for the planning and execution of Process Validation and Process Validation Support studies at facilities.
  • Individual will also be expected to provide support and leadership to Technology Transfer activities.

    Primary Tasks and Responsibilities

  • The role will involve the identification and analysis of available information required for Process Validation / Process Validation Support studies within operations.
  • Will be expected to plan and execute studies in association with Operations, QC, and Engineering personnel

    Other Skills, Experience and Education

  • 5yrs+ experience of working in an EU/FDA regulated environment.
  • Substantial experience of drafting plans & protocols and executing Validation support type studies in a Biotech environment. Of specific interest will be the areas of Cleaning Validation, Mixing Studies, Hold Studies, and the planning and implementation of Process Validation Batches.
  • Hands on experience of Technology Transfer would be of specific interest.
  • Plan & Implement "Process Validation" / "Pro Val Support" Studies.
  • Provide Technical support and leadership for Technology Transfer Teams.
  • Provide support and technical input to regulatory submissions and filings.
  • The person will have a minimum bachelors degree qualification in science or engineering.
  • The candidate should have a proven ability to work as part of a multidisciplinary team, and should be results focused with excellent communication and interpersonal skills
  • The candidate should have knowledge and experience of all relevant Environmental, Health and Safety regulations and guidelines.
  • The Candidate should have a proven ability and experience of, interacting with personnel from all levels within an organization


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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