2 дня назад
Staff Process Engineer PAR NPI/LCM (Pharmaceutical Manufacturing)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Staff Process Engineer PAR NPI/LCM (Pharmaceutical Manufacturing): Introducing parenteral drug products into commercial production and implementing filling processes with an accent on technology transfer, validation, compliance, and process robustness. Focus on executing engineering and validation batches, managing change controls and manufacturing documentation, and supporting audits and health authority responses.
Location: Schaffhausen, Switzerland
Company
Johnson & Johnson MedTech develops healthcare and pharmaceutical solutions focused on innovative treatments and patient outcomes.
What you will do
- Introduce new parenteral products into commercial manufacturing through technology transfer projects.
- Prepare and execute engineering runs, clinical batches, and validation batches with Operations, Engineering, and MSAT.
- Lead process improvement initiatives focused on robustness, compliance, cost improvement, and operational performance.
- Manage change controls, recipes, and process documentation.
- Train shop-floor and leadership teams on process changes and project content.
- Serve as a subject matter expert during audits, inspections, regulatory filings, and health authority responses.
Requirements
- Bachelor’s degree in natural sciences or engineering; a master’s degree is preferred.
- Preferably 4+ years of pharmaceutical industry experience, including at least 2 years in parenteral or pharmaceutical manufacturing or development.
- Knowledge of late-stage development and manufacturing operations such as compounding, milling, and filling liquid formulations and suspensions.
- Experience with manufacturing systems such as SAP, PAS-X, or equivalent.
- Strong planning, logistics, communication, influencing, and problem-solving skills.
- Proficiency in German and English is required.
Culture & Benefits
- Work within a healthcare innovation environment focused on developing treatments and improving patient outcomes.
- Collaborate with Operations, Engineering, MSAT, Production, and other business partners.
- Follow GMP, EHS, and SOX requirements.
- Inclusive work environment with support for applicant accommodations during the interview process.
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