Lateral Flow Process Engineer: Reel-to-Reel Systems

Yoh Idibu; Boulder (CO); On-site; USD 80,000 - 105,000; Full time

Benefits offered by this job

Medical, Prescription, Dental & Vision

Health Savings Account (HSA)

Life & Disability Insurance

MetLife Voluntary Benefits

Employee Assistance Program (EAP)

401K Retirement Savings Plan

Direct Deposit & weekly epayroll

Referral Bonus Programs

Certification and training

Job summary

Yoh Life Sciences in Longmont, Colorado, is seeking a Lateral Flow Process Engineer to support transfer and development of new products and processes. You will support manufacturing, while maintaining and improving upon existing equipment as well as ensuring product quality and yield.

This role requires knowledge of BioDot, Zeta, or Imagene Isoflow reel to reel systems, and a proven ability to perform DOE and SPC analyses in a regulated environment.

Qualifications

• Bachelor’s degree in engineering or related field; master’s preferred.
• Five to seven (5-7) years prior experience in an R&D or production environment with proven success of process improvement.
• Experience in a regulated environment.
• Excellent written and verbal communication skills; able to convey technical information to technical and non-technical staff.
• Excellent problem-solving and collaboration skills.
• Strong data gathering and analysis skills.
• Electro-mechanical equipment development and troubleshooting experience.
• Knowledge of QMS, deviation, CAPA and related quality requirements.

Responsibilities

• Lead sustaining support to operations using continuous improvement and root cause analysis.
• Utilize BioDot, Zeta, and Imagene Isoflow reel-to-reel systems.
• Ensure on-time equipment milestone deliveries to enable company growth.
• Recommend and implement equipment and process modifications to improve production efficiencies and yields.
• Develop high-level capital equipment integration protocols for manufacturing.
• Perform DOE and SPC analyses to target yield improvements and quality; manage data for GR&R, yield tracking, and CpK analysis.
• Document work products per IQ, OQ, PQ and cGMP standards.
• Collaborate with design staff to ensure compatibility of processes with equipment.
• Translate design requirements into production by defining tooling and processes.
• Author SOPs and detailed work instructions in accordance with GDP.
• Train manufacturing staff on proper processes and wave-guide instruments.
• Ensure compliance with safety rules and protocols.

Education

Bachelor’s degree in engineering or related field

Tools

BioDot

Zeta

Isoflow

Job description

Yoh Life Sciences in Longmont, Colorado, is seeking a Lateral Flow Process Engineer to support transfer and development of new products and processes. You will support manufacturing, while maintaining and improving upon existing equipment as well as ensuring product quality and yield.

This role requires knowledge of BioDot, Zeta, or Imagene Isoflow reel to reel systems, and a proven ability to perform DOE and SPC analyses in a regulated environment.