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AIQ Engineer

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Cognizant

25d ago

  • Job
    Full-time
    Senior Level
  • Research & Development
    Engineering
  • Cork

AI generated summary

  • You need a BSc in a technical field, 5+ years in Computer Systems Validation, strong problem-solving skills, FDA/EMEA knowledge, and excellent communication. Team-oriented and detail-focused.
  • You will manage Change Controls, author qualification documents, execute IOQ protocols, generate risk assessments, and serve as a key SME for AIQ during GMP audits.

Requirements

  • A BSc in Engineering, Computer Science, or other technical degree
  • 5+ years’ experience in a Computer Systems Validation role.
  • Excellent facilitation, problem solving, and decision-making skills.
  • Proven ability to analyse 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.
  • Be a strong teammate who is results and target oriented.

Responsibilities

  • Work with ELM team colleagues to deliver validation elements of Laboratory capital projects.
  • End to End ownership of Change Controls and their results.
  • Author\Review\Approve qualification documents for lab systems.
  • Work with site teams on generation of requirements and\or configuration of specifications 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.

FAQs

What is the job title for this position?

The job title is AIQ Engineer.

Where is this position located?

This position is located in Cork.

What kind of experience is required for the AIQ Engineer role?

A minimum of 5 years’ experience in a Computer Systems Validation role is required.

What educational background is preferred for this position?

A BSc in Engineering, Computer Science, or another technical degree is preferred.

What are the main responsibilities of the AIQ Engineer?

Main responsibilities include delivering validation elements of Laboratory capital projects, authoring and reviewing qualification documents, executing IOQ protocols for lab analytical instruments, and generating risk assessments.

What skills are important for the ideal candidate?

Important skills include facilitation, problem-solving, decision-making, excellent written and oral communication, and attention to detail.

Will the AIQ Engineer be involved in audits?

Yes, the AIQ Engineer will be a key Subject Matter Expert (SME) for the AIQ process for all GMP audits.

What kind of benefits does Cognizant offer for this position?

Cognizant offers an attractive salary, benefits package, opportunities for professional development, education, training, and wellness packages.

Is knowledge of FDA/EMEA regulatory requirements necessary for this role?

Yes, expert knowledge of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals, particularly Annex 11 & 21CFR Part 11, is necessary.

What qualities are emphasized for candidates?

Candidates should be strong teammates who are results and target-oriented.

Consulting
Industry
10,001+
Employees

Mission & Purpose

Cognizant is a multinational technology company that provides a wide range of IT services and solutions to organisations worldwide. Their primary focus is on helping businesses transform and thrive in the digital age. Cognizant's mission and purpose are centred around delivering innovative and cutting-edge technology solutions that drive client success. They offer services such as digital strategy, consulting, technology implementation, and IT outsourcing, enabling companies to adapt to evolving market dynamics, enhance operational efficiency, and deliver exceptional customer experiences. Cognizant's ultimate goal is to empower their clients with the tools, insights, and capabilities needed to navigate complex technological landscapes and achieve their business objectives in an increasingly digital world.