Senior Manufacturing Process Engineer - Life Sciences Scale-Up

Cellanome; Foster City (CA); On-site; USD 170,000 - 210,000; Full time

Benefits offered by this job

Stock options

Health plans

401(k)

Flexible work-life balance

Job summary

Cellanome in Foster City, CA is seeking a Senior Staff Manufacturing Process Engineer to scale and mature manufacturing for consumable components of our life science instrument platform. You will oversee LCM from NPI to continuous improvement and sustainment while supporting cross-functional teams throughout the product lifecycle.

Ideal candidates bring 12+ years in manufacturing/process engineering, hands-on cleanroom experience, and a track record of leading successful product introductions to

Qualifications

• Bachelor's degree in Mechanical, Chemical, Biochemical, Materials Science, or related Engineering; advanced degree preferred.
• Typically requires 12 years of progressive experience in manufacturing/process engineering, spanning NPI, continuous improvement and sustaining engineering within a consumables, medical device, or life sciences manufacturing environment.
• Experience leading new product introductions from development through full-scale production launch.
• Hands-on experience in cleanroom and ISO/cGMP manufacturing environments.
• Proficient in process validation methodologies (IQ/OQ/PQ), FMEA, root cause analysis, and CAPA processes.
• Working knowledge of statistical tools (SPC, DOE, Minitab/JMP) for process characterization and improvement.
• Proficient in utilizing AI tools to conduct experimental design, data analysis, build MFG KPI & SPC charting and monitoring systems.
• Excellent cross-functional communication and project management skills, with a proven ability to represent Operations on cross-functional teams and influence technical and business decisions.
• Ability to author, review, and maintain technical documentation (SOPs, protocols, work instructions, batch records).
• Demonstrated ability to perform the Essential Duties of the position with or without reasonable accommodations.

Responsibilities

• Lead new process transfer and qualification of new consumable manufacturing processes, transitioning products from R&D to full-scale production.
• Represent Consumable LCM on cross-functional teams, providing manufacturability input into design decisions.
• Own sustaining engineering support for released consumable products, including CAPA and deviation resolution.
• Identify and lead continuous improvement projects to improve yield, cycle time, capacity, and COGs.
• Develop tech transfer deliverables: product BOM, manufacturing process design, pFMEA, control plan, onboarding, work instructions.
• Complete operational readiness for new consumable products: batch records, space control, labeling & packaging readiness.
• Develop and apply Lean, Six Sigma, SPC, and DOE to optimize processes and reduce variation.
• Support hands-on troubleshooting and validation in manufacturing cleanroom environments.

Skills

Process engineering

NPI leadership

CAPA & RCA

Statistical tools (SPC/DOE)

Cross-functional collaboration

AI in experimental design

Documentation & SOPs

Education

Bachelor's degree in Mechanical, Chemical, Biochemical, Materials Science, or related Engineering

Advanced degree (MS/PhD) preferred

Tools

MFG ERP

MES

PLM

Web-based batch records

Minitab/JMP

Job description

Cellanome in Foster City, CA is seeking a Senior Staff Manufacturing Process Engineer to scale and mature manufacturing for consumable components of our life science instrument platform. You will oversee LCM from NPI to continuous improvement and sustainment while supporting cross-functional teams throughout the product lifecycle.

Ideal candidates bring 12+ years in manufacturing/process engineering, hands-on cleanroom experience, and a track record of leading successful product introductions to