锦鲤求职岗位描述
Process Analytics & Statistical Process Control (SPC) Engineer
SPC Engineer | Process Analytics | Manufacturing Data Analytics | Multiple Levels Open
Job Responsibilities:
We’re scaling our CPV capability to support rapid commercial growth, digital transformation (including Golden Batch platform), and robust lifecycle quality management. Whether you're launching your career or leading complex global programs — your expertise in data, statistics, and process science will directly impact product quality, regulatory confidence, and operational excellence.
You’ll:
Design, implement, and sustain statistical monitoring strategies (control charts, trend analysis, capability assessment) for critical processes and products
Analyze manufacturing, lab, and real-time data to detect variation, investigate root causes, and drive continuous improvement
Support regulatory readiness — from audit preparation and inspection response to submission documentation (BLA/MAA)
Collaborate cross-functionally with Manufacturing, QA/QC, Regulatory, Engineering, and R&D to embed data-driven decision-making
Contribute to advanced initiatives — including multivariate analytics, AI/ML modeling, digital platform integration, and CPV program evolution
Who You Are (Flexible by Level)
Requirement
Entry-Level
– Education: MS in Statistics, Engineering, Life Sciences, or related field
– Experience: 0–2 years — internships, thesis projects, or early industry exposure welcome
– Technical Fit: Solid foundation in statistics; curiosity about data & GMP; eager to learn tools like JMP, Minitab, or Python
– Mindset: Learner-first, detail-oriented, collaborative
Mid-Level
– Education: MS required; PhD preferred
– Experience: 2–4+ years in pharma/biotech — with hands-on CPV, SPC, DOE, or process analytics
– Technical Fit: Proven application of multivariate analysis, CAPA support, audit experience, or statistical modeling
– Mindset: Proactive problem-solver; strong cross-functional communicator
Leadership-Level
– Education: MS required; PhD preferred
– Experience: 4–8+ years — with CPV program ownership, regulatory engagement (e.g., FDA/EMA audits)
– Technical Fit: Track record in CPV strategy, digital implementation (e.g., Golden Batch platform), mentoring, or AI/ML-enabled monitoring
– Mindset: Strategic thinker; change agent; talent developer
Also valued across all levels:
Familiarity with ICH Q8–Q10, FDA/EMA CPV guidance, or GMP principles
Experience in biologics, cell/gene therapy, or small-molecule development/manufacturing
Be willing and able to work in China and other countries
Fluency in English (written & spoken); Chinese fluency a strong plus
Why Join us?
1. Join a highly dynamic CRDMO company with locations in China, APAC, Euro and USA
2. Working with cross-function teams with deep scientific and GMP manufacturing expertise
3. Offered opportunities to utilize and develop your lifecycle CMC experience in the pharmaceutical industry from process develop, tech transfer, and commercialization
4. Develop strong leadership and communication skills to facilitate contributions from different functions