2 дня назад
Process / Equipment Engineer (Biopharmaceutical)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Process / Equipment Engineer (Biopharmaceutical): Providing technical support for equipment and manufacturing processes in bio-vaccine suites with an accent on troubleshooting, validation, compliance, and equipment reliability. Focus on leading root-cause investigations, implementing CAPA and continuous improvements, supporting regulatory inspections, and contributing technical expertise to capital projects.
Location: Hybrid role based in Grange Castle, Dublin, Ireland; applicants must be legally authorized to live and work in Ireland. No relocation support is available.
Company
develops medicines and vaccines and applies digital and automated solutions to accelerate drug discovery, development, and manufacturing.
What you will do
- Provide routine equipment and process engineering support, troubleshooting manufacturing issues across the bio-vaccine suites.
- Lead root-cause investigations, product and process impact assessments, corrective actions, and CAPA implementation.
- Develop and execute cGMP validation, revalidation, periodic review, risk assessment, and IQ/OQ/PQ/QV documentation.
- Provide technical expertise during audits, regulatory inspections, change controls, investigations, and equipment requalification activities.
- Identify and implement equipment, process, safety, reliability, and continuous improvement initiatives.
- Represent Technical Operations Process Engineering on equipment reliability programs and capital project teams.
Requirements
- 3–5 years of industry experience, preferably in biopharmaceutical or pharmaceutical manufacturing.
- Experience with validation and revalidation systems, including equipment and manufacturing process qualification.
- Experience with compliance systems such as eQMS and QTS or similar platforms.
- Working knowledge of MCS and PI, plus experience with regulatory inspections.
- Strong communication and interpersonal skills with the ability to work independently in a fast-paced environment.
- Relevant authorization to live and work in Ireland is required.
Culture & Benefits
- Hybrid work arrangement.
- Work in a patient-centric environment focused on breakthroughs that change patients’ lives.
- Collaborate across Operations, Core Engineering, and Core Technical Services to promote right-first-time and zero-defect manufacturing.
- Inclusive workplace with support for reasonable adjustments during the application and interview process.
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