7 дней назад
Principal Manufacturing Systems Engineer (Biotech)
160 327 - 216 913$
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Описание вакансии
Текст:
TL;DR
Principal Manufacturing Systems Engineer (Biotech): Leading global manufacturing technology programs and product teams for GMP biotech manufacturing systems with an accent on MES, automation platforms, Agile delivery, and operational excellence. Focus on integrating OT platforms, managing roadmaps and financials, standardizing deployments, and ensuring data integrity and regulatory readiness.
Location: US – California – Thousand Oaks; the role may also be based at manufacturing locations in the US or Europe.
Salary: $160,327–$216,913 annually
Company
is a biotechnology company developing, manufacturing, and delivering medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.
What you will do
- Lead large capital projects and product teams delivering manufacturing systems in GMP environments.
- Prioritize demand, manage backlogs, and align site-level needs with global manufacturing technology strategy.
- Manage financials, resource planning, vendor performance, scope, schedules, and quality targets.
- Own the global operations technology roadmap, including upgrades, standardization, harmonization, and site deployments.
- Drive integration of MES, PI data, automation platforms, ERP, LIMS, historians, and enterprise data platforms.
- Present program progress, milestones, and risks to senior and executive leadership.
Requirements
- Doctorate with 2 years, master’s degree with 4 years, bachelor’s degree with 6 years, associate’s degree with 10 years, or high school diploma/GED with 12 years of Information Systems or Manufacturing Process Automation experience.
- Experience with manufacturing systems and platforms such as Aveva PI, DeltaV, Rockwell, or Körber MES.
- Strong knowledge of GMP manufacturing environments, GAMP software development lifecycles, ANSI/ISA-S88, ANSI/ISA-S95, and 21 CFR Part 11.
- Expertise in Agile methodologies and traditional waterfall project management.
- Experience managing cross-functional teams, project finances, stakeholders, and external system integrators.
- Ability to work from an manufacturing location in the US or Europe.
Nice to have
- Experience as a Product Owner or Scrum Master.
- Scientific domain expertise and experience with advanced digital manufacturing technologies.
- Consulting mindset with creativity and flexibility across changing program lifecycles.
Culture & Benefits
- Collaborative, innovative, and science-based work environment.
- Health, dental, vision, life, disability, and flexible spending benefits.
- Retirement and savings plan with company contributions.
- Annual bonus program and stock-based long-term incentives.
- Paid time-off plans and career development opportunities.
- Flexible work models where applicable to the work location.
Hiring process
- Applications are accepted until a sufficient number of candidates are received or a candidate is selected.
- Visa sponsorship is not guaranteed.
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