Director, Quality – Contamination Control, Microbial Excellence

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🕒 vor 6 Tagen

🏖️ New Jersey, North Carolina, +3 weitere Bundesländer – Remote

🏖️ New Jersey – Remote 🌲 North Carolina – Remote 🏈 Ohio – Remote 🍂 Massachusetts – Remote 🏰 Missouri – Remote

💵 $145.500 - $218.250 / Jahr

⏰ Vollzeit

🔴 Experte

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Thermo Fisher Scientific

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10.000+ Mitarbeiter

Gegründet 1956

🧬 Biotechnologie

💊 Pharmazie

🔬 Wissenschaft

Biotechnology • Pharmaceuticals • Science

Thermo Fisher Scientific ist der weltweite Marktführer im Dienste der Wissenschaft mit einem Jahresumsatz von mehr als 40 Milliarden US‑Dollar. Ihre Mission ist es, Kunden dabei zu unterstützen, die Welt gesünder, sauberer und sicherer zu machen – indem sie die lebenswissenschaftliche Forschung vorantreiben, komplexe analytische Herausforderungen lösen, die Produktivität in Laboren steigern und die Gesundheit von Patienten durch Diagnostik sowie die Entwicklung lebensverändernder Therapien verbessern. Mit einem globalen Team bietet das Unternehmen innovative Technologien und pharmazeutische Dienstleistungen über Marken wie Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon und PPD.

Beschreibung

• Support site based CCME colleagues to develop, implement, and maintain site contamination control strategies based on contamination control risk assessment in alignment with global quality procedures and EU GMP Annex 1, FDA 21 CFR, ISO and PIC/S • Provide subject matter expertise (SME) in microbiology, microbiological methods, contamination control, aseptic processing, Environmental Monitoring, cleanroom design, cleaning and disinfection and other relevant areas required by site CCME teams and corporate quality management • Support global review of EM trends from the PSG network and work with site teams to remediate adverse trends and maintain environmental control in all cleanrooms • Provide above-site support and direction to PSG sites for complex deviation or laboratory investigations related to Microbiology, Contamination Control and Sterility Assurance • Where appropriate, support with CAPA plan definition, preventive measures and continuous improvement initiatives • Provide above-site support and direction to PSG sites for complex risk assessments related to Microbiology, Contamination Control and Sterility Assurance • Provide guidance during facility and process design, including design led contamination controls and material/personnel and waste flows • Provide SME input into the qualification of manufacturing equipment and cleanroom that impact CCME including proper selection and validation of sterilization processes (e.g., autoclaves, SIP, filter integrity testing) • Inspection Readiness • Support digitalization and innovation across PSG sites

🎯 Anforderungen

• Bachelor’s or advanced degree in Microbiology, Pharmaceutical Sciences, Biotech, or a related field • 5–10 years experience in supporting sterile/low bioburden pharmaceutical manufacturing and/or microbiology roles • Strong understanding of aseptic manufacturing, cleanroom classification, disinfection, and contamination control • Deep knowledge of GMP, Annex 1 (2022 revision), FDA aseptic guidance • Understanding of barrier technologies (RABS, isolators) and their implementation • Effective communicator, able to influence and collaborate with cross-functional teams • Prior experience with regulatory inspections and audit defense • Experience with CCS implementation preferred

🏖️ Vorteile

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs • Employee assistance and family support programs, including commuter benefits and tuition reimbursement • At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy • Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan • Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount