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AstraZeneca

Global pharmaceutical company developing prescription medicines

Equipment Engineer - Cell Therapy

Regulatory & Quality (Life Sciences)Posted on Nov 13
Full-timeAmsterdam, NetherlandsNo salary listed

About the Job

Requirements

  • A bachelor's degree in Engineering, Life Sciences, or a related technical discipline, or equivalent experience.
  • Technical knowledge of and experience with storage equipment, such as storage vessels and related transport equipment.
  • Experience working in a GMP-regulated environment.
  • Understanding of how an Environmental Monitoring System works, including sensors and alarms.
  • Ability to discuss technical topics and write clear technical documentation in English.
  • Currently living within reasonable travel distance of One Helix because some alarms may require on-site attendance.

Responsibilities

  • Support the finalisation of F&E GMP documentation with consultants and internal colleagues.
  • Support development of procedures for Environmental Monitoring System failures and recovery to keep storage conditions under control.
  • Assist with storage equipment validation activities alongside the wider quality and engineering team to meet GMP requirements.
  • Contribute to preparing vendor Service Level Agreements, supporting clear performance expectations and follow-through.
  • Help establish and maintain processes for monitoring, alarm follow-up, and storage equipment maintenance.
  • Own and maintain the Environmental Monitoring System, supporting day-to-day upkeep alongside the wider team.
  • Support operator training on the Environmental Monitoring System and alarm procedures.
  • Assist with follow-up on alarms and technical failures, and flag product-quality risks to QA; this may occasionally require responding outside normal working hours while on-call arrangements are developed.
  • Support maintenance, calibration, and validation of cryogenic storage equipment and -80 °C freezers, working with colleagues who lead these activities.
  • Help coordinate vendors, change control, and technical documentation.
  • Support regulatory inspections involving the systems and equipment.

Desired Qualifications

  • Experience with qualification and validation; understanding the process is more important than being able to write protocols independently from day one.
  • Experience with Lighthouse Environmental Monitoring System and SAP.
  • Knowledge of data integrity requirements for GMP systems, such as ALCOA+ and 21 CFR Part 11.
  • Pharmaceutical experience, ideally involving cryogenic storage, cell therapy, or biologics.
  • Dutch language ability for technical discussions with local vendors.

About the Company

AstraZeneca

Global pharmaceutical company developing prescription medicines

AstraZeneca develops and markets prescription medicines and vaccines worldwide, with a focus on oncology, cardiovascular/metabolic, respiratory, and infectious diseases. Its products work by targeting specific biological pathways or cells, using small-molecule therapies, biologics, and vaccines to treat diseases or prevent infections. It differentiates itself through its dual heritage from Sweden and the UK, a broad pipeline, and strong R&D and collaborations that move from discovery to patient access. Its goal is to improve people’s health by discovering, developing, and delivering medicines and vaccines to patients worldwide.

Company size
10,001+
Company stage
IPO
Headquarters
Cambridge, United Kingdom
Founded
1913

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