Senior Staff Manufacturing Process Engineer at Cellanome · LumiJobs

Qualification

Bachelor's degree in MechanicalAbility to authorExperience with flow cellProject Management (PMP) certificationExperience with MFG ERPWhat you can expect from us

Required

Bachelor's degree in Mechanical, Chemical, Biochemical, Materials Science, or related Engineering discipline; 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.
Demonstrated experience leading new product introductions from development through full-scale production launch.
Strong hands-on experience in cleanroom and/or 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 or similar) 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.

Preferred

Experience with flow cell, microfluidics, reagents, or other single-cell/genomics consumable manufacturing.
Lean/Six Sigma Green Belt or Black Belt certification.
Project Management (PMP) certification.
Experience with manufacturing automation implementation and scale up.
Experience with MFG ERP, MES, PLM, and web-based batch record systems.
Prior experience in a fast-paced start-up environment, comfortable wearing multiple hats.
We provide competitive total compensation packages, including base pay, benefits, and equity. In California, the estimated base salary range for this position is $160,000- $210,000/year. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training.
What you can expect from us:

Senior Staff Manufacturing Process Engineer

Responsibilities

Qualification

Required

Preferred

Benefits

Company

Cellanome

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