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Job ID: JOB-13410
Title: CSV Engineer

Type: Full Time Employment

Location: Cork, Ireland

The client is a world leader in delivering digital transformation solutions to Life Sciences. Through their knowledge and expertise in Automation, MES & Digital, they deliver stable manufacturing systems that are optimised to improve operational efficiencies, whilst maintaining compliance. Their specialist engineering teams have the aptitude to deliver and support Pharma 4.0 architectures and solutions covering all IT, OT and IoT applications, infrastructures, and services.

The client have an exciting opportunity for an Analytical Instrument Qualification IT. This individual will join the Equipment Lifecycle Mgmt. (ELM) team and will be accountable for the execution of Laboratory Validation activities within the in AIQ framework.

Your typical day may include:

• Work with ELM team colleagues to deliver validation elements of Laboratory capital projects.
• End to End ownership of Change Controls and their results.
• AuthorReviewApproval of qualification documents for lab systems.
• Work with site teams on generation of requirement andor configuration specification and IOQ test protocols.
• Execution of IOQ protocols for lab analytical instruments.
• Generation of risk assessments.
• Be a key SME for the AIQ process for all GmP audits.

Qualifications and Requirements:

• A BSc in Engineering, Computer Science, or other technical degree
• 5+ years’ experience in analytical equipment validation role.
• Excellent facilitation, problem solving, and decision-making skills.
• Proven ability to analyze and define business problems, develop business cases, and identify appropriate process and technological solutions is critical.
• Expert Knowledge of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals in particular Annex 11 & 21CFR Part 11.
• Excellent written and oral communication skills and acute attention to detail.
• A strong teammate who is very results and target oriented.

What they’re about:

The client is passionate about their work and play vital roles across a range of professional fields, and care deeply about their customers and communities. The client culture enables dynamic and impactful careers. They share a kind of DNA where we’re each:

• Committed to caring
• Responsible to our communities
• Ready to apply our knowledge and know-how
• Rare in our background and experiences
• The drivers of our own success
• Passionate about doing what’s right

For further information on this role in Cork please contact Sinead Killalea on Consulting@hero.ie or 086-1287246

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Sinead Killalea

JOB-13410

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