Process Engineer, Manufacturing Sciences and Technology
Process Engineer, Manufacturing Sciences and Technology Gaithersburg, MD Tasks:
As a member of the team, you will analyze process technologies in support of new project proposals and assist in the technical transfer into the manufacturing group.
Additionally, you will work in a collaborative manner, coordinating the transfer of biological drug processes from process development (internal or client) groups in a CMO environment.
You will be responsible for manufacturing data collection and analysis and leading the technology transfer of small to medium scope clinical cell therapy projects for internal and external clients.
This role may serve as a process owner and may drive Continuous Improvement projects and Business Process Improvement activities of a medium scope.
As a result of your data tracking and trending, technology transfers, product lifecycle management and reporting, operations support, as well as your continuous improvement, you will support the continued success as a whole.
Among other responsibilities, you will:
Lead technology transfer of client (internal and external) cell therapy projects into Manufacturing.
Review, approve and/or author GMP documentation, protocols and reports.
Troubleshoot processing issues, including investigation for root cause and implementation of corrective and preventive action (CAPA) plans.
May serve as process owner and drives Continuous Improvement Projects.
May lead risk assessments, root cause analysis and similar activities.
Participate in research and development activities.
Lead multiple overlapping cross-functional technology transfer teams that include client technical staff and internal process development and manufacturing teams.
Identification of single-use process equipment of appropriate scale and quality for continued process improvement.
Prepare user requirements, obtain vendor quotes, and capital expenditure justification for equipment.
Provide technical information for the preparation of change controls, protocols, and new user training for the process equipment and processes.
Author/review process specifications and provide input for scale up and requirements for GMP manufacturing.
Author/review/approve batch records.
Author/review/approve Campaign summary reports, interim reports, manufacturing regulatory support documentation as applicable.
Assist with identifying raw materials and consumables of appropriate quality for the cGMP execution of client specified manufacturing processes;
Assist in the preparation of material specifications, vendor quotes, and the purchase of the materials.
Respond to client and/or internal staff questions or concerns about cGMP equipment, materials, and procedures.
Use key and critical process parameters and their associated critical quality attributes in the preparation of product specifications.
Provide data analysis from each manufacturing run that may be included in intermediate and/or final project summary reports and other team deliverables.
Contribute to and ensures the achievement of goals and tech transfer milestones on multiple projects with minimal delay in schedule or excessive use of resources.
Data tracking, trending, analysis and reporting.
Initial trainer of Manufacturing staff on process overviews and/or new equipment.
Requirements
Bachelor's Degree in Engineering, Chemistry, Biology, Life Sciences or related field or related scientific discipline.
2-5 years of relevant experience in a cGMP environment in relation to biologics and cell therapy manufacturing; or equivalent combination of education and experience.
Must be authorized to work in the US
Please note that this position may require vaccination against COVID-19, unless individual is entitled to reasonable accommodation under applicable law.
Preferred Skills:
Experienced with approving/revising cGMP related documents
Familiar with manufacturing planning and scheduling practices
Operational Excellence and Continuous Improvement Concepts (Six Sigma, Lean/Agile).
Understanding of statistical methods and/or software (JMP, Minitab, R)
Exposure to process/product development within a regulated environment
Microsoft Office (Excel, PowerPoint, Project, Word, Visio, Outlook, Teams)
Understanding of cGMP and regulations/guidance.
Can interpret guidance documents and make technical recommendations
Hands on process development or manufacturing experience with clinical scaleup projects
Experience with single-use manufacturing equipment and materials.
Understanding and experience in aseptic techniques.
cGMP Document writing experience including protocols, batch records, SOPs and summary reports and other associated Manufacturing documents.
#CGT You should know:
Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies.
A Kelly recruiter will confirm and share more details with you during the interview process.
Why Kelly (R) Science & Clinical? Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you.
Our team creates expert talent solutions to solve the world's most critical challenges.
Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it's the way we think job searching should be.
Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.
About Kelly (R) At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential.
In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?).
Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer.
We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities.
At Kelly, we believe that the more inclusive we are, the better services we can provide.
Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center.
Kelly complies with the requirements of California's state and local Fair Chance laws.
A conviction does not automatically bar individuals from employment.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
As a member of the team, you will analyze process technologies in support of new project proposals and assist in the technical transfer into the manufacturing group.
Additionally, you will work in a collaborative manner, coordinating the transfer of biological drug processes from process development (internal or client) groups in a CMO environment.
You will be responsible for manufacturing data collection and analysis and leading the technology transfer of small to medium scope clinical cell therapy projects for internal and external clients.
This role may serve as a process owner and may drive Continuous Improvement projects and Business Process Improvement activities of a medium scope.
As a result of your data tracking and trending, technology transfers, product lifecycle management and reporting, operations support, as well as your continuous improvement, you will support the continued success as a whole.
Among other responsibilities, you will:
Lead technology transfer of client (internal and external) cell therapy projects into Manufacturing.
Review, approve and/or author GMP documentation, protocols and reports.
Troubleshoot processing issues, including investigation for root cause and implementation of corrective and preventive action (CAPA) plans.
May serve as process owner and drives Continuous Improvement Projects.
May lead risk assessments, root cause analysis and similar activities.
Participate in research and development activities.
Lead multiple overlapping cross-functional technology transfer teams that include client technical staff and internal process development and manufacturing teams.
Identification of single-use process equipment of appropriate scale and quality for continued process improvement.
Prepare user requirements, obtain vendor quotes, and capital expenditure justification for equipment.
Provide technical information for the preparation of change controls, protocols, and new user training for the process equipment and processes.
Author/review process specifications and provide input for scale up and requirements for GMP manufacturing.
Author/review/approve batch records.
Author/review/approve Campaign summary reports, interim reports, manufacturing regulatory support documentation as applicable.
Assist with identifying raw materials and consumables of appropriate quality for the cGMP execution of client specified manufacturing processes;
Assist in the preparation of material specifications, vendor quotes, and the purchase of the materials.
Respond to client and/or internal staff questions or concerns about cGMP equipment, materials, and procedures.
Use key and critical process parameters and their associated critical quality attributes in the preparation of product specifications.
Provide data analysis from each manufacturing run that may be included in intermediate and/or final project summary reports and other team deliverables.
Contribute to and ensures the achievement of goals and tech transfer milestones on multiple projects with minimal delay in schedule or excessive use of resources.
Data tracking, trending, analysis and reporting.
Initial trainer of Manufacturing staff on process overviews and/or new equipment.
Requirements
Bachelor's Degree in Engineering, Chemistry, Biology, Life Sciences or related field or related scientific discipline.
2-5 years of relevant experience in a cGMP environment in relation to biologics and cell therapy manufacturing; or equivalent combination of education and experience.
Must be authorized to work in the US
Please note that this position may require vaccination against COVID-19, unless individual is entitled to reasonable accommodation under applicable law.
Preferred Skills:
Experienced with approving/revising cGMP related documents
Familiar with manufacturing planning and scheduling practices
Operational Excellence and Continuous Improvement Concepts (Six Sigma, Lean/Agile).
Understanding of statistical methods and/or software (JMP, Minitab, R)
Exposure to process/product development within a regulated environment
Microsoft Office (Excel, PowerPoint, Project, Word, Visio, Outlook, Teams)
Understanding of cGMP and regulations/guidance.
Can interpret guidance documents and make technical recommendations
Hands on process development or manufacturing experience with clinical scaleup projects
Experience with single-use manufacturing equipment and materials.
Understanding and experience in aseptic techniques.
cGMP Document writing experience including protocols, batch records, SOPs and summary reports and other associated Manufacturing documents.
#CGT You should know:
Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies.
A Kelly recruiter will confirm and share more details with you during the interview process.
Why Kelly (R) Science & Clinical? Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you.
Our team creates expert talent solutions to solve the world's most critical challenges.
Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it's the way we think job searching should be.
Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.
About Kelly (R) At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential.
In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?).
Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer.
We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities.
At Kelly, we believe that the more inclusive we are, the better services we can provide.
Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center.
Kelly complies with the requirements of California's state and local Fair Chance laws.
A conviction does not automatically bar individuals from employment.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
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