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Job Requirements of Validation Specialist II:
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Employment Type:
Full-Time
-
Location:
Swiftwater, PA (Onsite)
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Validation Specialist II
Icon Information Consultants
Swiftwater, PA (Onsite)
Full-Time
Role: Validation Specialist II
Support: Recombinant Vaccine Project
Location: Swiftwater, Pennsylvania, USA
About Us
Manufacturing, Sciences, Analytics & Technology (MSAT) at our Swiftwater, Pennsylvania site is part of the largest vaccine manufacturing facility in the United States. We are dedicated to advancing our manufacturing assets to produce both existing and new vaccines and biopharmaceuticals, ensuring public health and scientific excellence.
The Position
As a **Validation Specialist II** within the MSAT team, you will play a vital role in supporting manufacturing processes to achieve industrial excellence. Your primary focus will be on ensuring the accuracy, conformity, and competitiveness of manufacturing processes and techniques used for vaccine and biologics production at Sanofi’s industrial sites.
The MSAT function is committed to delivering robust and efficient process validation and testing, with effective know-how transfer to Manufacturing & Quality Control (QC). Additionally, MSAT provides daily operational support to optimize manufacturing and QC performance.
Key Responsibilities
- Lead and execute process validation activities, including validation strategy development, protocol writing, and documentation.
- Manage process validation runs such as Process Performance Qualification (PPQ), development runs, upstream/downstream processing, and cell culture processes.
- Write comprehensive validation reports, deviation investigations, and technical documentation with proficiency.
- Make independent decisions to troubleshoot and resolve issues during validation activities.
- Support continuous improvement initiatives to enhance process robustness and efficiency.
- Collaborate closely with manufacturing and QC teams to ensure seamless process transfer and validation execution.
- Maintain flexibility to accommodate process schedules, including harvesting at non-standard hours (e.g., midnight shifts), with normal hours typically from 8 AM to 4 PM.
Preferred Qualifications
- Proven experience in process validation within a biologics or vaccine manufacturing environment.
- Experience with process development, PPQ, and upstream/downstream processing.
- Strong technical writing skills and ability to manage validation documentation independently.
- Ability to work autonomously, make sound decisions, and adapt to changing priorities and schedules.
- Flexibility to support batch manufacturing activities outside standard hours when necessary.
---
Ideal Candidate
The best fit for this role is someone with a solid background in process validation, particularly in biologics or vaccine manufacturing. Candidates with a mix of process experience and equipment validation are also encouraged to apply.
Work Schedule & Flexibility
- Primarily first shift (8 AM – 4 PM), with potential adjustments based on operational needs.
- Ability to support validation activities that may require working outside typical hours, including overnight or weekend shifts when necessary.
Support: Recombinant Vaccine Project
Location: Swiftwater, Pennsylvania, USA
About Us
Manufacturing, Sciences, Analytics & Technology (MSAT) at our Swiftwater, Pennsylvania site is part of the largest vaccine manufacturing facility in the United States. We are dedicated to advancing our manufacturing assets to produce both existing and new vaccines and biopharmaceuticals, ensuring public health and scientific excellence.
The Position
As a **Validation Specialist II** within the MSAT team, you will play a vital role in supporting manufacturing processes to achieve industrial excellence. Your primary focus will be on ensuring the accuracy, conformity, and competitiveness of manufacturing processes and techniques used for vaccine and biologics production at Sanofi’s industrial sites.
The MSAT function is committed to delivering robust and efficient process validation and testing, with effective know-how transfer to Manufacturing & Quality Control (QC). Additionally, MSAT provides daily operational support to optimize manufacturing and QC performance.
Key Responsibilities
- Lead and execute process validation activities, including validation strategy development, protocol writing, and documentation.
- Manage process validation runs such as Process Performance Qualification (PPQ), development runs, upstream/downstream processing, and cell culture processes.
- Write comprehensive validation reports, deviation investigations, and technical documentation with proficiency.
- Make independent decisions to troubleshoot and resolve issues during validation activities.
- Support continuous improvement initiatives to enhance process robustness and efficiency.
- Collaborate closely with manufacturing and QC teams to ensure seamless process transfer and validation execution.
- Maintain flexibility to accommodate process schedules, including harvesting at non-standard hours (e.g., midnight shifts), with normal hours typically from 8 AM to 4 PM.
Preferred Qualifications
- Proven experience in process validation within a biologics or vaccine manufacturing environment.
- Experience with process development, PPQ, and upstream/downstream processing.
- Strong technical writing skills and ability to manage validation documentation independently.
- Ability to work autonomously, make sound decisions, and adapt to changing priorities and schedules.
- Flexibility to support batch manufacturing activities outside standard hours when necessary.
---
Ideal Candidate
The best fit for this role is someone with a solid background in process validation, particularly in biologics or vaccine manufacturing. Candidates with a mix of process experience and equipment validation are also encouraged to apply.
Work Schedule & Flexibility
- Primarily first shift (8 AM – 4 PM), with potential adjustments based on operational needs.
- Ability to support validation activities that may require working outside typical hours, including overnight or weekend shifts when necessary.
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