Lateral Flow Process Engineer

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 is hiring for a Lateral Flow Process Engineer in Longmont, CO for a leading diagnostic company.

The Lateral Flow Process Engineer will 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 candidate must have knowledge of BioDot, Zeta, or Imagene Isoflow reel to reel systems.

Responsibilities

• Lead efforts to provide sustaining support to operations utilizing continuous improvement principles and technical support to operations utilizing root cause analysis to implement corrective actions.
• Utilizing BioDot,Zeta, orImagene Isoflow reel to reel systems.
• Enables company growth by ensuring on-time equipment milestone deliveries.
• Recommends and implements equipment and process modifications to improve production efficiencies, manufacturing techniques and production yields for existing products.
• Assists in developing high level capital equipment integration protocols and procedures for manufacturing.
• Develops and conducts statistical analysis such as Design of Experiments (DOE) and Statistical Process Control (SPC) targeting physical cause of failure for yield loss and improving quality. Active database and data management allowing for process performance assessment via GR&R, Yield Tracking and Cpk analysis.
• Accurately documents all work products to ensure equipment qualifications and in line with and follow IQ, OQ, PQ requirements.
• Interacts with design staff to ensure that processes and designs are compatible with existing equipment.
• Translate design requirements into production by defining, designing and/or communicating efficient and capable process tooling.
• Utilizing GDP, author documents including but not limited to manufacturing Standard Operating Procedures (SOPs), and detailed work instructions.
• Trains manufacturing staff on proper processes to follow when operating equipment, including wave-guide instrument(s).
• Ensures that team and staff members follow safety rules and protocol.

Experience

• Bachelor’s degree in engineering or related field required; master’s degree preferred.
• Experience with BioDot,Zeta, orImagene Isoflow reel to reel systems.
• Five to seven (5-7) years prior experience in an R&D or production environment with proven success of process improvement and scale-up projects.
• Experience in a regulated environment.
• Excellent written and verbal communication skills; able to communicate technical information to technical and non-technical staff to ensure understanding.
• Excellent problem-solving skills and demonstrated ability to collaborate in problem solving.
• Excellent data gathering and analysis skills.
• Excellent electro-mechanical equipment development and troubleshooting skills.
• Knowledge of QMS, including experience with deviation, CAPA, and other quality related objectives and requirements.

#IND-SPG

Estimated Min Rate: $80000.00

Estimated Max Rate: $105000.00

What’s In It for You?

Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• MetLife Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities

Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant’s experience, technical expertise, and other qualifications as listed in the job description.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

To learn more about Yoh’s privacy practices, please see our Candidate Privacy Notice: https://www.yoh.com/privacy-notice