Senior Process Engineer

1 week ago

San Diego, California, United States Maravai LifeSciences Full time
About Maravai LifeSciences

Maravai LifeSciences is a global leader 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.

Job Summary

We are seeking a highly skilled Senior Process Engineer to join our engineering team. 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.

Key Responsibilities
  • Provide technical leadership and expertise to production operations
  • 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)
Requirements
  • 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
What We Offer
  • Competitive salary range: $112,000 - $120,000
  • Long-term incentives in the form of company equity, bonus participation and company sponsored benefits
  • Comprehensive medical plans and HSA/FSA options
  • Fertility & family planning assistance
  • A variety of additional optional benefits 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.maravailifesciences.com/careers/benefits

To view more opportunities to become a #MiracleMaker, visit our career site at https://www.maravailifesciences.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.

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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 careers@maravailifesciences.com. If you believe you have been a victim of fraud, you can report this activity at https://www.ic3.gov/complaint/default.aspx or https://www.ftc.gov/complaint

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