Sr Engineer - OQSIE
Cambridge, MA
About the Job
JOB SUMMARY
As an Engineer in the Drug Substance Technology & Engineering Team, you will be responsible for the technology transfer and commercial support of biologics drug substance processes across the network, including both the Client manufacturing network and/or Contract Manufacturing Organizations. You will work as a member of a team of engineers and scientists, as you use engineering principles to implement manufacturing process in a cGMP environment.
Domestic and International Travel: up to 15%
SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
• Provide solutions to a variety of technical problems of moderate scope and complexity.
• Under general supervision will evaluate, select and apply standard engineering techniques and procedures. Assistance given for unusual problems.
• Perform assignments that have clear and specific objectives and require investigation of limited number of variables.
• Initiate and complete routine technical tasks.
• Function as a technical expert to equipment or systems regarding troubleshooting operations. Frequently become actively involved in daily operations when required to meet schedules or to resolve complex problems.
• Routinely monitor manufacturing processes for performance indicators and operations. Suggest problem resolution and provide troubleshooting guidance.
• Apply engineering principles and statistical analysis, including design of experiments, in-order to solve processing issues and evaluate opportunities for process improvements
• Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for processes and/or system modifications.
• Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints.
• Work with consultants, architects and engineering firms on development of standard design documents.
• Communicate and collaborate with technical and management staff within Manufacturing, Process Development, and Quality departments.
• Support non-standard shift organization and extended hours, as per business needs.
Basic Qualifications
Master's degree
OR Bachelor's degree and 2 years of Engineering or Operations experience
OR Associate's degree and 6 years of Engineering or Operations experience
OR High school diploma / GED and 8 years of Engineering or Operations experience
Preferred Qualifications
• Education background in Chemical Engineering, Bioengineering or Biotechnoloy
• 2+ years of experience in a Process Development/Process Engineering environment, with specific experience in the implementation and support of biopharmaceutical manufacturing processes.
• Experience in process scale-up and technology transfer from laboratory to pilot and/or manufacturing scale
• Experience working with commercial manufacture of biologics using single use technology
• Basic understanding cGMP requirements
• Experience related to upstream and/or downstream biologics process development technology transfer, scale-up and ongoing manufacturing of biologics (cGMP). This includes technical support for nonconformance investigations and other commercial support activities
• Experience in working with design and optimization of pharmaceutical processing unit operations including cell expansion, harvest, clarification, Protein A, IEX, SEC, TFF, UFDF, and sterile filtration among others for a variety of biological molecules
• Experience in the analysis of data generated from a variety of analytical techniques
• Regulatory knowledge and interactions
• Project management skills
• Strong oral and verbal communication and presentation skills
• Fluency in foreign languages preferred
As an Engineer in the Drug Substance Technology & Engineering Team, you will be responsible for the technology transfer and commercial support of biologics drug substance processes across the network, including both the Client manufacturing network and/or Contract Manufacturing Organizations. You will work as a member of a team of engineers and scientists, as you use engineering principles to implement manufacturing process in a cGMP environment.
Domestic and International Travel: up to 15%
SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
• Provide solutions to a variety of technical problems of moderate scope and complexity.
• Under general supervision will evaluate, select and apply standard engineering techniques and procedures. Assistance given for unusual problems.
• Perform assignments that have clear and specific objectives and require investigation of limited number of variables.
• Initiate and complete routine technical tasks.
• Function as a technical expert to equipment or systems regarding troubleshooting operations. Frequently become actively involved in daily operations when required to meet schedules or to resolve complex problems.
• Routinely monitor manufacturing processes for performance indicators and operations. Suggest problem resolution and provide troubleshooting guidance.
• Apply engineering principles and statistical analysis, including design of experiments, in-order to solve processing issues and evaluate opportunities for process improvements
• Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for processes and/or system modifications.
• Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints.
• Work with consultants, architects and engineering firms on development of standard design documents.
• Communicate and collaborate with technical and management staff within Manufacturing, Process Development, and Quality departments.
• Support non-standard shift organization and extended hours, as per business needs.
Basic Qualifications
Master's degree
OR Bachelor's degree and 2 years of Engineering or Operations experience
OR Associate's degree and 6 years of Engineering or Operations experience
OR High school diploma / GED and 8 years of Engineering or Operations experience
Preferred Qualifications
• Education background in Chemical Engineering, Bioengineering or Biotechnoloy
• 2+ years of experience in a Process Development/Process Engineering environment, with specific experience in the implementation and support of biopharmaceutical manufacturing processes.
• Experience in process scale-up and technology transfer from laboratory to pilot and/or manufacturing scale
• Experience working with commercial manufacture of biologics using single use technology
• Basic understanding cGMP requirements
• Experience related to upstream and/or downstream biologics process development technology transfer, scale-up and ongoing manufacturing of biologics (cGMP). This includes technical support for nonconformance investigations and other commercial support activities
• Experience in working with design and optimization of pharmaceutical processing unit operations including cell expansion, harvest, clarification, Protein A, IEX, SEC, TFF, UFDF, and sterile filtration among others for a variety of biological molecules
• Experience in the analysis of data generated from a variety of analytical techniques
• Regulatory knowledge and interactions
• Project management skills
• Strong oral and verbal communication and presentation skills
• Fluency in foreign languages preferred
Source : OQSIE