AIT Laboratory Equipment Qualification Engineer

Orion Group Life Sciences are currently recruiting an AIT Laboratory Equipment Qualification Engineer on behalf of our Multinational Biopharmaceutical client based in Co. Meath on an initial 11-month contract (with potential for extension).

Role Description:

• The AIT Labs Engineer will be responsible for delivery of Automation and IT scope on one or more lab projects in the portfolio of capital projects.
• This candidate will be required to work closely with the AIT teams responsible for the full Automation and IT scope and with vendors / partners with responsibility for qualification of laboratory systems.

Responsibilities:

• Partner with local project teams to deliver Automation and IT aspects of Laboratory capital projects.
• Develop and/or review System Development Life Cycle (SDLC) deliverables, compliant with company standards. Consult with site AIT group to add input to site SOPs for lab systems.
• Author\Review\Approval of qualification documents for lab systems - RS, CS, RTM etc.
• Work with site teams on generation of requirement and\or configuration specification and IOQ test protocols. Participate in execution of IOQ protocols for lab analytical instruments where required.
• Provide input to the development of project schedules and document trackers.
• Generate risk assessments\variance documentation and interface with site teams to close out same.
• Work closely with the DDQ function to ensure compliance with company Quality standards.
• Interface with site teams for Enterprise system deliverables such as Empower, LIMS, MODA, LabX and Acronis etc.
• Drive efficiencies in execution of projects to reduce costs and cycle times based on standards.
• Ensures that SDLC is appropriately applied.

Knowledge, Skills, Education:

• BSc in Engineering, Computer Science, and or other technical degree.
• 5 or more years of experience in project/automation/IT/CSV/IT and or a similar role with experience in laboratory analytical instrument qualification and system implementation.
• Excellent facilitation, problem solving, collaboration and decision-making skills.
• Ability to multitask and to manage tasks with competing priorities effectively and engage with stakeholders.
• Demonstrated ability to troubleshoot, problem solve, analyse, and define business problems, develop business cases, and identify appropriate process and technological solutions are essential.
• Proven facilitation, meeting/workshop management, project management and change management skills are essential.
• Excellent written, oral communication skills, as well as strong presentation skills.
• Experience with Laboratory systems such as Empower LIMS, MODA, LabX and Acronis.
• Experience in automation equipment used in biopharma laboratories is an advantage.

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.