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Validation Engineer

  • Job reference: 926548
  • Location: Cork
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Engineering, Manufacturing & Facilities, Life Sciences
  • Date posted: 11/07/2019

Orion Group are looking for a Validation Engineer for our multinational medical devices client based in the Cork area on an initial 12-month contract with the potential to extend.

Job Purpose
The primary purpose of this job is to support major Manufacturing Engineering Projects.
The position is part of a team within the Engineering department that contributes to the overall
business metrics. This position will provide project leadership on continuous improvement, and
risk mitigation initiatives and will also include liaison with outside suppliers and other client
Design & Manufacturing sites to ensure all goals and targets of the manufacturing process are

Main Responsibilities of the role

  • Competent in validation requirements on new processes, equipment introductions &
    process changes
  • Responsible for performing process validation studies by following approved standard
    operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other
    regulatory requirements
  • Process Validation for process creation
  • Process Validation for the transfer of processes within the facility
  • Defines the requirements for Process Validation studies in alignment with approved SOPs
  • Executes test plans according to approved procedures, performs sampling, tabulates test
    results, and organizes data packages
  • Compiles and analyses validation data, prepares reports and makes recommendations for
    changes and/or improvements
  • May also investigate and trouble-shoot problems which occur, and determine solutions
  • Coordinates and executes validation change control and preparation of draft protocols,
    reports and data tables
  • Maintains and archives all documentation pertaining to validation
  • Participates on cross-functional project teams with the support of Development,
    Manufacturing, Engineering, Quality, and other groups
  • As required, prepares summaries of validation testing for regulatory submissions, and
    presents validations to regulatory agencies
  • Independently applies validation principles to work assignments, reviews and approves
    documents and resolves problems
  • Coordinates assigned projects and represents department on project teams
  • Resolves validation issues of moderate scope with limited direct supervision

Desired Experience and Background of the successful candidate

  • Qualification in an appropriate discipline (e.g. Engineering, Information Systems, or Life Science with additional IT qualification) with a broad technical/educational skills base
  • Minimum of 2 years working in a regulated environment a minimum 1 of which has been spent carrying out validation and/or testing activities
  • Knowledge of bespoke validation, Process knowledge and documentation
  • In depth knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry
  • High understanding of GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations
  • Working experience of validation computer systems for use in a FDA regulated environment
  • Extensive understanding and application of validation principles, concepts, practices, and
    standards particularly in relation to Process Validation
  • Proficient in current Good Manufacturing Practices (GMPs)
  • Full knowledge of industry practices
  • Strong verbal, written, and interpersonal communication skills are required
  • Investigation and report writing skills
  • Proficient in Microsoft Office applications
  • Experience in Statistical analysis is essential
  • Experience in regulated industry, FDA, ISO, etc.
  • Demonstrated leadership skills and the ability to make effective decision
  • Ability to manage multiple assignments or projects with sound analytical, troubleshooting,
    and problem solving skills
  • Degree of responsibility - must be capable of taking direction and taking responsibility and
    ownership for systems
  • Extent of confidentiality - discretion is essential in view of contact with outside parties, product development strategies, regulatory and sales information

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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