team leadershiphvacgmpdata integritypharmaceutical manufacturingquality systemscalibrationcmmsprocess instrumentation
Вакансия из Hirify Global, списка международных tech-компаний Для мэтча и отклика нужен Plus
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Зарплата и рынок
Мало
€52к/год
€47к€60кмедиана€74к
По похожим ролям (50) ~ €60к/год
На СНГ рынке: $2.5к/мес ($1.8к - $3к)
65
Средняя вакансия
развернуть
Роль четко определена с ясными обязанностями, но зарплата ниже рыночной, что может снизить ее привлекательность.
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Низкая зарплатаЧеткие обязанностиСильная репутация компанииГибридный формат работы
Оценка от Hirify AI
Мэтч & Сопровод
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Описание вакансии
Текст:
Hirify AI/Оригинал
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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