CQV Engineer

2 days ago

Dublin, Dublin City, Ireland WuXi Biologics Group Full time

A true single-source provider from concept to commercialization for biologics produced from mammalian cell culture.

As CQV Engineer (Thermal Mapping) you will be responsible for thermal mapping activities for the upstream and downstream packages to enable start-up of the processing facility and for the ongoing activities during sustaining operations. The Thermal Mapping Specialist is responsible for ensuring that all manufacturing and Warehouse processes and QC systems perform and operate as per their design. The Thermal Mapping Specialist ensures that all systems conform to relevant regulatory requirements as well as company specifications and standards.

Organisation Description

WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. We´re one of the world's top three contract development and manufacturing companies for biopharmaceuticals, we provide our clients with a world-leading open access technology platform. We enable our clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing.

Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide. We have sites/offices in China, the US, the EU, Asia, and Israel. We currently employ over 10,000 people and provide services to more than 200 customers worldwide, including 13 of the top 20 biopharmaceutical companies.

Department Description

As CQV Engineer (Thermal Mapping) you'll be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role you will be reporting to the Thermal Systems Validation Lead.

Your Responsibilities

  1. Review Protocols / Reports for Equipment Commissioning & Qualification activities on-site, including URS, Risk Assessments, DQ, FAT, SAT, IOQ, PQ.
  2. Co-ordinate/ perform all temperature mapping and validation of equipment such as fridges, freezers, autoclaves, incubators, stability cabinets and SIP systems.
  3. Maintain SOPs / WIs associated with Qualification & Validation studies.
  4. Ensure Project related work is carried out in accordance with the requirements of Validation Policies, Guidelines, Site Validation Master Plan and GMP.
  5. Sterilization / sanitization validations site-wide, as required.
  6. Temperature distribution studies site wide, as required.
  7. Co-ordinate / perform other Performance Qualification and Re-qualification / Re-Validation studies, as relevant.
  8. Generation of reports / analysis of data against pre-determined criteria to GMP standards.
  9. Perform all duties in accordance with GMP requirements, SOPs, and controlled documents.
  10. Will be flexible to take on additional tasks and responsibilities at the discretion of the Thermal Systems Validation Lead.
  11. Will act as a role model for the Engineering function and the wider organisation in adherence to the WuXi corporate core values and PROUD culture.

Your Profile

The ideal candidate for this position will have the following:

Education

  • A degree in a life-science / engineering related discipline is required.

Knowledge/Experience

Required:

  • Minimum of 3 years' experience in thermal mapping.
  • A good understanding of the bio-pharmaceutical industry including GMP and relevant validation requirements.

Personal skills

  • Excellent communication, interpersonal and presentation skills.
  • Collaborative and inclusive approach to work and your colleagues.
  • Excellent problem solving and troubleshooting skills.
  • Flexible approach to work and a positive attitude will be a good fit within the team dynamic.
  • Engage cross functionally in conjunction with a site-based team.
  • Autonomous and a self-starter who will use their initiative to drive actions forward.
  • Demonstrate strong ethics in adhering to company procedures and policies, regulatory standards, and our customers' expectations.
  • Drive a Continuous Improvement Culture within the Engineering team.

As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential

If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our mission - Any drug can be made, and any disease can be treated - don't miss out on this opportunity to join us and reach beyond yourself and discover your true potential.

WuXi Biologics is an equal opportunities employer.

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