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Validation Engineer 30022

  • Job reference: 932053
  • Location: Dublin South, Dublin
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Engineering, Manufacturing & Facilities, Life Sciences
  • Date posted: 21/09/2020

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

Validation oversight of External Manufacturing sites (API, DS/DP), including process, cleaning, filter and sterilization/sanitization validation activities.

Major Responsibilities:

  • Be an integral quality member of cross-functional contract manufacturing team that includes but is not limited to business operations, analytical science, process development, supply chain XPD etc.
    * Translates company requirements into the language of the CMO-can make a risk-based decision
    * Validation document author/approver
    * Ensure validated parameters are correctly incorporated in Master Batch Records
    * Regulatory - Aseptic processing system oversight (media fill, autoclave validation, EM) content authorship
    * Validation change control assessment
    * Perform Person in Plant activities as required
    * Author applicable MA filing sections
    * Write/review RTQs
    * Prepare inspection playbooks
    * Present on topics during inspection demonstrating appropriate behaviors and knowledge of the subject areas
    * Drive Operational Excellence and Champion Change
    * Determine validation strategy and outcome of validation activities
    * Decision to approve or reject validation documentation
    * Provide Validation position on related topics and strategy for the sit

Experience/Background

  • Degree qualified in science and/or engineering
    * 5 + years (ideally 8 years +) biotech or pharmaceutical industry experience
    * Significant Validation experience at Aseptic Manufacturing or API facilities
    * Able to facilitate and influence senior stakeholders and partners
    * Able to successfully manage workload and timelines
    * Familiarity with basic project management tools
    * Ability to negotiate a strategic position after taking feedback from multiple sources (dealing with CMOs, communicate with others where English isn't first language)
    * Strong project management, problem-solving, and analytical skills
    * Collaborates and communicates well with others, able to balance divergent inputs from various stakeholders and drive issue resolution
    * Ability to operate in a matrixed or team environment with site, functional, and executive leadership
    * Experience driving decision making

For more information on this role, call Kate O' Sullivan on +353 (0) 212063412 or email Kate.OSullivan@orioneng.com for a completely confidential chat about this role and other opportunities using the reference number:932053


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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