- Support manufacturing toward industrial excellence to guarantee the accuracy, conformity, and competitiveness of the processes and techniques utilized to produce the vaccines and biologics manufactured onsite.
- Write protocols, reports, procedures, and memos as needed to support viral vaccine drug substance manufacturing activities as they relate to engineering, investigational, definition, development and process validation runs.
- Support execution of development and validation related studies.
- Input design space/ DOE studies through establishment of scale-up/scale-down parameters utilizing engineering fundamentals and process control strategies.
- Partner with engineering to ensure industrial implementation of process design, including review of engineering design documents, provide review and input to C&Q strategy and participating in testing of equipment.
- Provide technical assistance to manufacturing and quality operations for process troubleshooting improvement, technical transfer, and health authority inspections to achieving site metrics (+QDCI).
- Bachelor of Science or Master of Science in basic sciences, math, engineering, or pharmacy with 2+ years' experience or PHD with experience in process validation is required.
- Prior work experience with process validation and qualification is required.
- Product development experience is highly desirable.
- Prior working experience with drug substance, cell culture, downstream/upstream purification is highly desirable.
- Prior working experience in a GMP environment is required.
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Validation Specialist III
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Validation Specialist III
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Stark Associates LLC Swiftwater, United StatesJob Description Job Description Job Role: Validation Specialist III Location: Swiftwater, PA Contract: W2 MUST HAVES; 1) Experience in cleaning validation in the biologics or vaccine industry. 2) Cleaning Validation experience Acceptance criteria determination 3) Rinse and Swab s ...
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Validation Specialist III
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Pyramid Consulting Swiftwater, United StatesImmediate need for a talented Validation Specialist III (Engineering). This is a 12+ months Contract opportunity with long-term potential and is located in Swiftwater, PA(Onsite). Please review the job description below and contact me ASAP if you are interested. · Job ID: (phone ...
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Validation Specialist III
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Pyramid Consulting Swiftwater, United StatesImmediate need for a talented · Validation Specialist III (Engineering). · This is a · 12+ months Contract · opportunity with long-term potential and is located in · Swiftwater, PA(Onsite). · Please review the job description below and contact me ASAP if you are interested. ...
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Validation Specialist III
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The Fountain Group Swiftwater, United StatesJob Description: · Support manufacturing toward industrial excellence to guarantee the accuracy, conformity, and competitiveness of the processes and techniques utilized to produce the vaccines and biologics manufactured onsite. · Write protocols, reports, procedures, and memos a ...
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Democratic Physician Group
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Emergency Care Partners Chillicothe, MO, United StatesOPPORTUNITY · We are seeking an Emergency/Family Medicine Board Certified/ Board Eligible physician to join our patient-centered democratic physician group at Hedrick Medical Center, a Saint Luke s Health System campus, just outside of the great Kansas City community in Chillico ...
Validation Specialist III - Swiftwater, United States - The Fountain Group
