Quality Assurance Sr. Engineer (Drug Product)
Posted on Sep 15, 2024 by Fujifilm
Holly Springs, NC
Research
Immediate Start
Annual Salary
Full-Time
Overview:
Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO
The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.
Join us
We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.
The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.
External US:
About This Role
During Project phase:
• Partners in the Quality oversight of Drug Product processes such as formulation, fill, inspection through to operational readiness, as well as provide oversight of validation program execution for these processes
• Generates, reviews, and approves QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility
• Performs other duties, as assigned
During Operations:
• Performs as subject matter expert within the QA team for the development of documents, processes, and procedures for the Drug Product program
• Assesses the impact of system and process modifications and maintains oversight of change management processes to ensure Manufacturing Systems are first validated and then maintained in a validated state through startup and into commercial operation.
• Provides oversight and approval of system and process lifecycle documentation, including risk and impact assessments, product, process and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports
• Generates, reviews, and approves QA procedures for the validation approach and lifecycle documents for Manufacturing Systems
• Actively seeks opportunities to collaborate and align with other FUJIFILM Diosynth Biotechnologies sites to streamline processes and maximize efficiency
• Ensures project and operational quality objectives are met within desired timelines
• Participates in optimization or improvement initiatives and support regulatory agency and third-party inspections
• Performs other duties, as assigned
Minimum Requirements
• Bachelor’s degree in Life Sciences or Engineering with 9+ years of applicable industry experience OR
• Master’s degree in Life Sciences or Engineering and 6+ years of applicable experience OR
• PhD in Life Sciences or Engineering and 3+ years of applicable experience
• 5+ years of experience in GMP Quality Assurance and/or similar role
• Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility
Preferred Requirements
Prior experience of one or more of the following processes preferred.
formulation
aseptic filling
automated visual inspection
finished goods manufacturing.
Prior experience and knowledge with Quality Risk Management Principles
Advanced Understanding of cell culture, upstream processes, large scale recovery and/or downstream processes
Expertise in cGMP & FDA regulations
Experience with startup projects or initiatives
Occasional opportunity for International and/or Domestic travel may be available
Working & Physical Conditions
Ability to stand for prolonged periods of time up to 30 minutes
Ability to sit for prolonged periods of time up to 120 minutes
FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email .
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO
The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.
Join us
We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.
The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.
External US:
About This Role
During Project phase:
• Partners in the Quality oversight of Drug Product processes such as formulation, fill, inspection through to operational readiness, as well as provide oversight of validation program execution for these processes
• Generates, reviews, and approves QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility
• Performs other duties, as assigned
During Operations:
• Performs as subject matter expert within the QA team for the development of documents, processes, and procedures for the Drug Product program
• Assesses the impact of system and process modifications and maintains oversight of change management processes to ensure Manufacturing Systems are first validated and then maintained in a validated state through startup and into commercial operation.
• Provides oversight and approval of system and process lifecycle documentation, including risk and impact assessments, product, process and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports
• Generates, reviews, and approves QA procedures for the validation approach and lifecycle documents for Manufacturing Systems
• Actively seeks opportunities to collaborate and align with other FUJIFILM Diosynth Biotechnologies sites to streamline processes and maximize efficiency
• Ensures project and operational quality objectives are met within desired timelines
• Participates in optimization or improvement initiatives and support regulatory agency and third-party inspections
• Performs other duties, as assigned
Minimum Requirements
• Bachelor’s degree in Life Sciences or Engineering with 9+ years of applicable industry experience OR
• Master’s degree in Life Sciences or Engineering and 6+ years of applicable experience OR
• PhD in Life Sciences or Engineering and 3+ years of applicable experience
• 5+ years of experience in GMP Quality Assurance and/or similar role
• Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility
Preferred Requirements
Prior experience of one or more of the following processes preferred.
formulation
aseptic filling
automated visual inspection
finished goods manufacturing.
Prior experience and knowledge with Quality Risk Management Principles
Advanced Understanding of cell culture, upstream processes, large scale recovery and/or downstream processes
Expertise in cGMP & FDA regulations
Experience with startup projects or initiatives
Occasional opportunity for International and/or Domestic travel may be available
Working & Physical Conditions
Ability to stand for prolonged periods of time up to 30 minutes
Ability to sit for prolonged periods of time up to 120 minutes
FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email .
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
Reference: 200080939
https://jobs.careeraddict.com/post/95232569
Quality Assurance Sr. Engineer (Drug Product)
Posted on Sep 15, 2024 by Fujifilm
Holly Springs, NC
Research
Immediate Start
Annual Salary
Full-Time
Overview:
Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO
The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.
Join us
We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.
The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.
External US:
About This Role
During Project phase:
• Partners in the Quality oversight of Drug Product processes such as formulation, fill, inspection through to operational readiness, as well as provide oversight of validation program execution for these processes
• Generates, reviews, and approves QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility
• Performs other duties, as assigned
During Operations:
• Performs as subject matter expert within the QA team for the development of documents, processes, and procedures for the Drug Product program
• Assesses the impact of system and process modifications and maintains oversight of change management processes to ensure Manufacturing Systems are first validated and then maintained in a validated state through startup and into commercial operation.
• Provides oversight and approval of system and process lifecycle documentation, including risk and impact assessments, product, process and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports
• Generates, reviews, and approves QA procedures for the validation approach and lifecycle documents for Manufacturing Systems
• Actively seeks opportunities to collaborate and align with other FUJIFILM Diosynth Biotechnologies sites to streamline processes and maximize efficiency
• Ensures project and operational quality objectives are met within desired timelines
• Participates in optimization or improvement initiatives and support regulatory agency and third-party inspections
• Performs other duties, as assigned
Minimum Requirements
• Bachelor’s degree in Life Sciences or Engineering with 9+ years of applicable industry experience OR
• Master’s degree in Life Sciences or Engineering and 6+ years of applicable experience OR
• PhD in Life Sciences or Engineering and 3+ years of applicable experience
• 5+ years of experience in GMP Quality Assurance and/or similar role
• Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility
Preferred Requirements
Prior experience of one or more of the following processes preferred.
formulation
aseptic filling
automated visual inspection
finished goods manufacturing.
Prior experience and knowledge with Quality Risk Management Principles
Advanced Understanding of cell culture, upstream processes, large scale recovery and/or downstream processes
Expertise in cGMP & FDA regulations
Experience with startup projects or initiatives
Occasional opportunity for International and/or Domestic travel may be available
Working & Physical Conditions
Ability to stand for prolonged periods of time up to 30 minutes
Ability to sit for prolonged periods of time up to 120 minutes
FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email .
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO
The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.
Join us
We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.
The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.
External US:
About This Role
During Project phase:
• Partners in the Quality oversight of Drug Product processes such as formulation, fill, inspection through to operational readiness, as well as provide oversight of validation program execution for these processes
• Generates, reviews, and approves QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility
• Performs other duties, as assigned
During Operations:
• Performs as subject matter expert within the QA team for the development of documents, processes, and procedures for the Drug Product program
• Assesses the impact of system and process modifications and maintains oversight of change management processes to ensure Manufacturing Systems are first validated and then maintained in a validated state through startup and into commercial operation.
• Provides oversight and approval of system and process lifecycle documentation, including risk and impact assessments, product, process and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports
• Generates, reviews, and approves QA procedures for the validation approach and lifecycle documents for Manufacturing Systems
• Actively seeks opportunities to collaborate and align with other FUJIFILM Diosynth Biotechnologies sites to streamline processes and maximize efficiency
• Ensures project and operational quality objectives are met within desired timelines
• Participates in optimization or improvement initiatives and support regulatory agency and third-party inspections
• Performs other duties, as assigned
Minimum Requirements
• Bachelor’s degree in Life Sciences or Engineering with 9+ years of applicable industry experience OR
• Master’s degree in Life Sciences or Engineering and 6+ years of applicable experience OR
• PhD in Life Sciences or Engineering and 3+ years of applicable experience
• 5+ years of experience in GMP Quality Assurance and/or similar role
• Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility
Preferred Requirements
Prior experience of one or more of the following processes preferred.
formulation
aseptic filling
automated visual inspection
finished goods manufacturing.
Prior experience and knowledge with Quality Risk Management Principles
Advanced Understanding of cell culture, upstream processes, large scale recovery and/or downstream processes
Expertise in cGMP & FDA regulations
Experience with startup projects or initiatives
Occasional opportunity for International and/or Domestic travel may be available
Working & Physical Conditions
Ability to stand for prolonged periods of time up to 30 minutes
Ability to sit for prolonged periods of time up to 120 minutes
FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email .
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
Reference: 200080939
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