Maravai LifeSciences
Senior Process Engineer
Maravai LifeSciences, San Diego, California, United States, 92189
Who we are
:
Maravai LifeSciences translates extraordinary science into everyday miracles, helping biotech, biopharma, and life sciences companies everywhere deliver novel vaccines, therapeutics, and diagnostics. We are global leaders in providing products and services within the fields of nucleic acid production and biologics safety testing to many of the world's leading biopharma, vaccine, diagnostics, and cell and gene therapy companies.
At Maravai, we believe that diverse perspectives are the foundation of innovation.
Through an inclusive and
equitable
culture where every team member is inspired to bring their best selves to work, we cultivate an environment in which we can lead together,
providing
differentiated value to our customers, and enabling the miracles of science.
For over 35 years,
Maravai's
portfolio companies have served as a catalyst for innovative, lifesaving technology for humanity. Pioneering nucleotide research since its
inception
, we are now leading the way in the rapidly expanding mRNA market
.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
able 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 organizations such as Research & Development, Manufacturing, Supply Chain, Legal, IT, Supply Chain, 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 but not limited to 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 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.The benefits of being a #Mirac
le
Maker:
You have the potential to change,
improve
, and save lives around the world.
You have the opportunity to be a part
o
wner in
Maravai through RSU grants and
optional
employee stock purchase plans
.
We
offer comprehensive
medical plans
and
H
SA
/FSA
options
.
Fertility &
family planning
assistance
.
A variety of
additional
optional benefit
s
and insurance options, including
pet insurance.
Retirement
contributions
.
Holidays & Paid Time Off
.
Benefits may vary by region and employment type and do not apply to temporary employees or contractors. See a comprehensive list of benefits at our
Benefits & growth
site at https://www.maravai.com/careers/benefits-and-growth/
To view
more
opportunities
to become a #MiracleMaker
,
visit
our career site at
https://www.maravai.com/careers/
Maravai
LifeSciences is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual
orientation
,
and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
Click here to view Maravai LifeSciences Privacy Notice
HIRING SCAM ALERT
Recently, individuals impersonating Maravai LifeSciences Human Resources members have offered fraudulent interviews and job offers to unsuspecting candidates. To help protect you from these
scam
artists, please be aware that:
Maravai LifeSciences will never interview a candidate over RingCentral, similar messaging apps or social media (e.g. Telegram, Google Hangouts, WhatsApp, Facebook Messenger, etc.)
Maravai LifeSciences will never send a company check or ask an applicant to pay a fee or purchase at home work/training materials in connection with an application for employment.
Maravai LifeSciences will never provide excess money to an applicant and ask the applicant to write a check for repayment.
If you have any doubt about a job offer or any other communication purporting to come from Maravai LifeSciences, please reach out to us directly at
taops@maravai.com
. If
you
believe you have been a victim of fraud, you can report this activity at:
www.iC3.gov
or
www.stopfraud.gov
.
#J-18808-Ljbffr
:
Maravai LifeSciences translates extraordinary science into everyday miracles, helping biotech, biopharma, and life sciences companies everywhere deliver novel vaccines, therapeutics, and diagnostics. We are global leaders in providing products and services within the fields of nucleic acid production and biologics safety testing to many of the world's leading biopharma, vaccine, diagnostics, and cell and gene therapy companies.
At Maravai, we believe that diverse perspectives are the foundation of innovation.
Through an inclusive and
equitable
culture where every team member is inspired to bring their best selves to work, we cultivate an environment in which we can lead together,
providing
differentiated value to our customers, and enabling the miracles of science.
For over 35 years,
Maravai's
portfolio companies have served as a catalyst for innovative, lifesaving technology for humanity. Pioneering nucleotide research since its
inception
, we are now leading the way in the rapidly expanding mRNA market
.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
able 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 organizations such as Research & Development, Manufacturing, Supply Chain, Legal, IT, Supply Chain, 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 but not limited to 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 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.The benefits of being a #Mirac
le
Maker:
You have the potential to change,
improve
, and save lives around the world.
You have the opportunity to be a part
o
wner in
Maravai through RSU grants and
optional
employee stock purchase plans
.
We
offer comprehensive
medical plans
and
H
SA
/FSA
options
.
Fertility &
family planning
assistance
.
A variety of
additional
optional benefit
s
and insurance options, including
pet insurance.
Retirement
contributions
.
Holidays & Paid Time Off
.
Benefits may vary by region and employment type and do not apply to temporary employees or contractors. See a comprehensive list of benefits at our
Benefits & growth
site at https://www.maravai.com/careers/benefits-and-growth/
To view
more
opportunities
to become a #MiracleMaker
,
visit
our career site at
https://www.maravai.com/careers/
Maravai
LifeSciences is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual
orientation
,
and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
Click here to view Maravai LifeSciences Privacy Notice
HIRING SCAM ALERT
Recently, individuals impersonating Maravai LifeSciences Human Resources members have offered fraudulent interviews and job offers to unsuspecting candidates. To help protect you from these
scam
artists, please be aware that:
Maravai LifeSciences will never interview a candidate over RingCentral, similar messaging apps or social media (e.g. Telegram, Google Hangouts, WhatsApp, Facebook Messenger, etc.)
Maravai LifeSciences will never send a company check or ask an applicant to pay a fee or purchase at home work/training materials in connection with an application for employment.
Maravai LifeSciences will never provide excess money to an applicant and ask the applicant to write a check for repayment.
If you have any doubt about a job offer or any other communication purporting to come from Maravai LifeSciences, please reach out to us directly at
taops@maravai.com
. If
you
believe you have been a victim of fraud, you can report this activity at:
www.iC3.gov
or
www.stopfraud.gov
.
#J-18808-Ljbffr