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Job ID: JOB-13427

We know it’s not all about the money when you’re looking for your next Commissioning, Qualification and Validation Engineer job but we also know it’s important too!  HERO are working with a global leader in Pharmaceuticals to find the very best of talent for their Dundalk operation.  Why should you apply?  This Commissioning, Qualification and Validation Engineer job opportunity in Dundalk offers exceptional career development opportunities whilst delivering excellent salary and benefits package. 

Let’s talk to see if this is the right move for you.

Key Responsibilities

• Accountable to provide quality oversight to QC instruments/equipment qualification activities to ensure these activities are compliant with all applicable regulations and company and procedures.
• Accountable for review and approval of commissioning and qualification activities, including the pre and post-execution review & approval of all validation lifecycle documents.
• Accountable for providing guidance on creation of equipment lifecycle documentation, e.g. URS, SAT, IQ, OQ, PQ protocols and reports, risk assessments, technical specifications, 21 CFR Part 11 assessment/Data Integrity Assessment, Configuration Specifications, Design specifications.
• Participate or lead investigation, where possible related to discrepancies identified during qualification activities
• Review & approve SOPs, Deviations/Event, CAPAs, Change Controls, Periodic Maintenance plans and user access request’s etc..
• Effective interfaces with internal and external stakeholders to ensure effective communication
• Align with company’s Quality Goal and Strategy to set the Quality Goal, as well as monitor result and employee performance
• Provide guidance to operation personnel regarding commissioning, qualification and validation. Work with the team on continuous improvement activities.
• Comply with company requirements on EHS
• Perform other tasks as assigned by QA department management.
• Other responsibilities as assigned by QA management.

Requirements:

• Minimum bachelor’s degree in biology, biotechnology, or relevant discipline
• Minimum 6 years of QA experience in the biotech/pharmaceutical industry, preferable in vaccine or biologics or commercial product experience, CDMO experience also preferred but not required.
• Good understanding of cGMP requirements, GCPs, GLPs, GAMP and Part 11 compliance as applied to quality assurance, qualification of systems and validation of biotech/pharmaceutical manufacturing processes
• Excellent knowledge of validation principles
• Thorough working knowledge of regulations and industry best practice affecting product quality.

For further information on this role please contact Danielle Quinn on 086 044 9371 or engineering@hero.ie 

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.

Danielle Quinn

JOB-13427

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