Maravai and Kirkland & Ellis LLP
Senior Process Engineer
Maravai and Kirkland & Ellis LLP, San Diego, California, United States, 92189
Your next role as a Miracle Maker
Maravai LifeSciences is seeking a #MiracleMaker to join our engineering team as a Senior Process Engineer. As a Senior Process Engineer, you will operate with limited management oversight on complex projects and act as technical lead for process equipment and business sustainment. Job responsibilities will include providing technical leadership and expertise to production operations. This role will work actively in a multi-functional team environment, collaborating and liaising with organizations such as Research & Development, Manufacturing, Supply Chain, Legal, IT, Maintenance, Validation, and Quality Assurance in support of new and current manufacturing processes.
How you will make an impact:
Support equipment and processes across TriLink facilities
Design and implement new process equipment as required by new processes or process scale-up
Identify and implement efficiency and safety improvements to existing process equipment
Develop SOPs and support recipe development
Support process and technology transfers of NPIs from R&D to manufacturing
Provide support for tech transfer for commercialization of pharmaceutical and biotech products
Collaborate on a cross-functional team to define technical requirements for new products and processes
Independently design and execute experimental protocols, interpreting data from different sources/formats, using statistical analysis, and preparing scientific/operations development reports
Troubleshoot and resolve equipment issues on the production floor
Review and develop technical information for the process such as Hazard Information/data, P&IDs, Material of Const. Compatibility, PFDs (Process Flow Diagrams), Unit operation Sequence, Material (including consumables) & Energy Balances, and Equipment operating procedures
Develop and support implementation of process learning and qualification
Drive and lead projects that impact the company’s revenue and business strategy
Coach and mentor Process Engineers I & II in design, process understanding, problem-solving, troubleshooting, and project management
Stay current with industry trends on modern manufacturing technologies (process automation, novel processing equipment, and disposable technologies)
Perform other functions and duties as required
The skills and experience that you will bring:
BS in Chemistry, Chemical Engineering, Mechanical Engineering, or related field with at least 5 years of experience in a cGMP industrial setting, or MS / PhD in Chemistry, Chemical Engineering, Biochemical Engineering, or related field with 2 or more years of experience in cGMP industrial setting
Verbal and communication skills, including ability to present complex information clearly and concisely, required
Experience in small and large molecule scale-up in pharmaceutical development
Experience with a variety of process equipment (e.g., equipment for reactions, crystallization, Tangential Flow Filtration (TFF), chromatography) is strongly preferred
Strong understanding of Statistical Process Control (SPC) and statistical knowledge (DOEs, statistical analysis, statistical software, etc.) is strongly preferred
Experience with cGMP, ICH & PDA guidelines, process validation, project management, and control strategy development strongly preferred
Experience with automated equipment control systems (DCS / SCADA) highly desired
Familiarity with nucleoside/nucleotide chemistry, Oligo synthesis is desirable
Experience working in a self-driven, performance/results oriented, fast-paced environment, preferred
Experience working collaboratively as an engineering team and with other departments
Proficiency in Excel, Word, PowerPoint is preferred
Experience with root-cause analysis tools such as DMAIC and leading process FMEA and risk management exercises is preferred and six sigma certified is a plus
Experience with 21 CFR 820, ICH Q7, ISO 9001, and/or ISO 13485 requirements a plus
The anticipated salary range for this position is $112,000 - $120,000. In addition, highly competitive long-term incentives in the form of company equity, bonus participation, and company-sponsored benefits are provided as part of the total compensation package. The salary offer will depend on multiple factors which may include the successful candidate's skills, experience, and other qualifications, as well as the location of the role.
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Maravai LifeSciences is seeking a #MiracleMaker to join our engineering team as a Senior Process Engineer. As a Senior Process Engineer, you will operate with limited management oversight on complex projects and act as technical lead for process equipment and business sustainment. Job responsibilities will include providing technical leadership and expertise to production operations. This role will work actively in a multi-functional team environment, collaborating and liaising with organizations such as Research & Development, Manufacturing, Supply Chain, Legal, IT, Maintenance, Validation, and Quality Assurance in support of new and current manufacturing processes.
How you will make an impact:
Support equipment and processes across TriLink facilities
Design and implement new process equipment as required by new processes or process scale-up
Identify and implement efficiency and safety improvements to existing process equipment
Develop SOPs and support recipe development
Support process and technology transfers of NPIs from R&D to manufacturing
Provide support for tech transfer for commercialization of pharmaceutical and biotech products
Collaborate on a cross-functional team to define technical requirements for new products and processes
Independently design and execute experimental protocols, interpreting data from different sources/formats, using statistical analysis, and preparing scientific/operations development reports
Troubleshoot and resolve equipment issues on the production floor
Review and develop technical information for the process such as Hazard Information/data, P&IDs, Material of Const. Compatibility, PFDs (Process Flow Diagrams), Unit operation Sequence, Material (including consumables) & Energy Balances, and Equipment operating procedures
Develop and support implementation of process learning and qualification
Drive and lead projects that impact the company’s revenue and business strategy
Coach and mentor Process Engineers I & II in design, process understanding, problem-solving, troubleshooting, and project management
Stay current with industry trends on modern manufacturing technologies (process automation, novel processing equipment, and disposable technologies)
Perform other functions and duties as required
The skills and experience that you will bring:
BS in Chemistry, Chemical Engineering, Mechanical Engineering, or related field with at least 5 years of experience in a cGMP industrial setting, or MS / PhD in Chemistry, Chemical Engineering, Biochemical Engineering, or related field with 2 or more years of experience in cGMP industrial setting
Verbal and communication skills, including ability to present complex information clearly and concisely, required
Experience in small and large molecule scale-up in pharmaceutical development
Experience with a variety of process equipment (e.g., equipment for reactions, crystallization, Tangential Flow Filtration (TFF), chromatography) is strongly preferred
Strong understanding of Statistical Process Control (SPC) and statistical knowledge (DOEs, statistical analysis, statistical software, etc.) is strongly preferred
Experience with cGMP, ICH & PDA guidelines, process validation, project management, and control strategy development strongly preferred
Experience with automated equipment control systems (DCS / SCADA) highly desired
Familiarity with nucleoside/nucleotide chemistry, Oligo synthesis is desirable
Experience working in a self-driven, performance/results oriented, fast-paced environment, preferred
Experience working collaboratively as an engineering team and with other departments
Proficiency in Excel, Word, PowerPoint is preferred
Experience with root-cause analysis tools such as DMAIC and leading process FMEA and risk management exercises is preferred and six sigma certified is a plus
Experience with 21 CFR 820, ICH Q7, ISO 9001, and/or ISO 13485 requirements a plus
The anticipated salary range for this position is $112,000 - $120,000. In addition, highly competitive long-term incentives in the form of company equity, bonus participation, and company-sponsored benefits are provided as part of the total compensation package. The salary offer will depend on multiple factors which may include the successful candidate's skills, experience, and other qualifications, as well as the location of the role.
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