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Instruments Calibration Manager (Biopharmaceutical Manufacturing)

52 000€
Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
Italy
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Instruments Calibration Manager (GMP biopharmaceutical manufacturing): Leading the calibration program for utilities and process equipment at a pharmaceutical manufacturing site with an accent on GMP compliance, data integrity, and inspection readiness. Focus on defining risk-based calibration strategies, managing deviations and CAPAs, supporting equipment qualification and validation, and developing the calibration team.

Location: Onsite in Nerviano, Milan, Italy.

Salary: minimum €52,000 annually, plus eligibility for an annual performance bonus.

Company

hirify.global is an international research-focused biopharmaceutical group operating in more than 30 countries, with manufacturing sites in Italy, France, and Brazil.

What you will do

  • Lead the site calibration program for utilities and process equipment in a GMP-regulated manufacturing environment.
  • Develop and maintain the calibration master plan, including schedules, intervals, tolerances, acceptance criteria, and risk-based strategies.
  • Manage calibration records, certificates, documentation, data integrity, inspection readiness, and calibration status for critical instruments.
  • Coordinate internal resources and external service providers, and support qualification, validation, commissioning, and start-up of new equipment and utilities.
  • Manage deviations, investigations, change controls, CAPAs, KPIs, audits, and continuous improvement initiatives related to calibration.
  • Lead and develop the calibration team while promoting safety, quality, and operational excellence.

Requirements

  • Degree in Engineering or a related scientific discipline, or a technical diploma.
  • At least 5 years of experience in calibration, maintenance, engineering, or technical services within the pharmaceutical or another GMP-regulated industry.
  • Strong knowledge of calibration principles for process instrumentation and utility systems.
  • Experience with GMP regulations, data integrity principles, and pharmaceutical quality systems.
  • Knowledge of HVAC, Purified Water, Water for Injection (WFI), Clean Steam, and Compressed Air utilities.
  • Experience with filling lines, packaging equipment, CIP/SIP systems, and manufacturing equipment.
  • Familiarity with CMMS and calibration management systems.
  • Experience managing contractors and external calibration service providers.
  • Experience supporting regulatory inspections by FDA and AIFA.
  • Excellent written and spoken English.

Culture & Benefits

  • Benefits include pension, private medical insurance, a wellbeing programme, and a flexible benefits programme.
  • Healthcare programmes and work-life balance initiatives are provided.
  • Relocation support and tax assistance services are available for foreign colleagues.
  • Flexible working arrangements and remote work options are offered as part of the broader employment package.
  • Access to development resources and training.
  • Commitment to sustainability, diversity, inclusion, reliability, transparency, and ethical behaviour.

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