3 дня назад
Manufacturing Associate I (Sterile Injectables)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Manufacturing Associate I (Sterile Injectables): Performing aseptic and non-aseptic manufacturing operations for sterile injectable products with an accent on equipment preparation, compounding, formulation, filtration, and fill-finish activities. Focus on executing GMP procedures, maintaining aseptic technique, completing batch documentation, and supporting investigations, validation, and cross-functional manufacturing activities.
Location: York, United States; manufacturing work in a GMP facility with extended shifts and a variable schedule when required.
Company
provides pharmaceutical development and manufacturing services through BioTechnique, a sterile injectable full-service CDMO specializing in formulation, compounding, fill-finish, and lyophilization.
What you will do
- Perform routine and critical aseptic and non-aseptic manufacturing operations for sterile injectable products.
- Prepare equipment for production, including CIP and SIP operations.
- Execute compounding, filtration, formulation, filling, and primary processing activities according to manufacturing instructions and SOPs.
- Maintain aseptic gowning certification, perform room sanitization, and follow proper aseptic techniques.
- Complete batch records, logbooks, forms, and other production documentation in accordance with Good Documentation Practices.
- Identify and document deviations, participate in investigations, support commissioning and validation, and collaborate with engineering, warehouse, and facilities teams.
Requirements
- High school diploma and 1–2 years of experience in a mechanically based or similar role.
- 1–2 years of manufacturing experience in an FDA-regulated pharmaceutical facility preferred.
- Experience with controlled documents and sterile injectable drugs preferred.
- Familiarity with formulation, filling, primary packaging, aseptic processing, and aseptic techniques preferred.
- Ability to follow written procedures, complete multiple floor activities, and maintain strong attention to detail and quality.
- Strong communication, analytical, organizational, prioritization, and mechanical aptitude skills; experience with Microsoft Office and Excel.
Culture & Benefits
- Medical, dental, and vision coverage, with PSC paying 100% of qualifying employee medical premiums and 50% for qualifying dependents.
- Employee assistance programs, basic life insurance, short- and long-term disability coverage, and other insurance options.
- 401(k) plan with matching, PTO, sick time, and paid holidays.
- Education assistance, pet insurance, fitness benefits, and financial discounts.
- Coaching and professional development opportunities in a multicultural organization.
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