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QC/Validation Engineer

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CAI

1mo ago

  • Job
    Full-time
    Mid Level
  • Science
    Engineering
  • Limerick
  • Quick Apply

AI generated summary

  • You need a BS/MS in a relevant field, 3+ years of experience, strong communication and problem-solving skills, and proficiency in life science manufacturing. Willingness to travel is required.
  • You will ensure quality compliance in equipment qualifications, assist with documentation, review processes, monitor timelines, manage quality control, and collaborate with vendors throughout testing.

Requirements

  • BS or MS in a relevant science or engineering field, or equivalent experience.
  • 3+ years of industry related experience
  • Strong oral and written communication skills, with a focus on clear documentation and reporting.
  • Excellent problem-solving skills with a Quality Control mindset.
  • Strong customer-service orientation.
  • Proficient in life science manufacturing processes such as biotech, aseptic fill/finish, oral solid dose (OSD), and gene therapy, or with equivalent experience.
  • Willing and able to travel domestically and internationally, if required.

Responsibilities

  • Support Quality Control compliance throughout all equipment qualification activities, ensuring safety and regulatory standards are met.
  • Assist in the documentation and execution of equipment qualification processes, from initial assessments through to Operational Qualification (OQ), with an emphasis on accuracy and quality.
  • Follow established procedures and protocols for new equipment qualification to embed quality practices within workflows.
  • Review and complete Test Outlines and Procedures (TOPs) to verify alignment with quality specifications.
  • Help plan and organize commissioning materials and consumables, ensuring they meet quality requirements.
  • Monitor equipment qualification activities to ensure timelines are met without compromising quality standards.
  • Prepare and maintain Qualification Summary Reports (QSRs) and related documentation to confirm adherence to quality standards.
  • Participate in equipment Design Evaluations, Factory Acceptance Testing (FAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), maintaining a focus on quality outcomes.
  • Manage quality control processes related to equipment qualifications, including documentation control, change controls, and punch list tracking.
  • Work closely with project contractors and equipment vendors to perform and verify tests, ensuring strict quality control is maintained.
  • Support quality assurance tasks throughout the equipment qualification process to ensure consistent quality standards are upheld.

FAQs

What is the job title for this position?

The job title is QC/Validation Engineer.

Where is the job located?

The job is located in Ireland, North Europe.

What company is hiring for this position?

CAI is the company hiring for this position.

What type of company is CAI?

CAI is a 100% employee-owned company that provides commissioning, qualification, validation, start-up, project management, and consulting services in FDA regulated and mission-critical industries.

What are the primary responsibilities of the QC Technician?

The primary responsibilities include supporting Quality Control compliance, assisting in equipment qualification processes, reviewing Test Outlines and Procedures, monitoring qualification activities, and managing quality control processes related to equipment qualifications.

What are the educational requirements for this position?

A BS or MS in a relevant science or engineering field, or equivalent experience is required.

How many years of experience are needed for this role?

A minimum of 3 years of industry-related experience is required.

Are there any specific skills that are emphasized for this position?

Yes, strong oral and written communication skills, problem-solving skills with a Quality Control mindset, and a strong customer-service orientation are emphasized.

Is travel required for this position?

Yes, the candidate should be willing and able to travel domestically and internationally if required.

What types of manufacturing processes should candidates be familiar with?

Candidates should be proficient in life science manufacturing processes such as biotech, aseptic fill/finish, oral solid dose (OSD), and gene therapy, or have equivalent experience.

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CAI

We unite talent and technology to power the possible for our clients, colleagues, and communities.

Technology
Industry
5001-10,000
Employees
1981
Founded Year

Mission & Purpose

CAI is a global technology services firm with over 8,700 associates worldwide and a yearly revenue of $1 billion+. We have over 40 years of excellence in uniting talent and technology to power the possible for our clients, colleagues, and communities. As a privately held company, we have the freedom and focus to do what’s right—whatever it takes. Our tailor-made solutions create lasting results across the public and commercial sectors, and we are trailblazers in bringing neurodiversity to the enterprise.