Process Engineer II - GMP Equipment Lifecycle

Lumen Bioscience, Inc.; Seattle (WA); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Health, Dental, Vision fully covered

401k match up to 4%

Generous PTO and paid holidays

Wellness program

Job summary

Lumen Bioscience, Inc. is seeking a Process Engineer II to manage the lifecycle of GMP manufacturing equipment, from onboarding and commissioning through qualification, validation and decommissioning.

You will partner with Engineering and Process Development to optimize processes on production-scale equipment. The role requires 5+ years of related experience, strong hands-on troubleshooting, and experience with IQ/OQ/PQ.

Qualifications

• Bachelor’s degree in an engineering discipline is required.
• 5+ years of relevant process or equipment engineering experience, preferably in a cGMP pharmaceutical, biotechnology, or medical device environment.
• Experience supporting equipment qualification and validation (IQ / OQ / PQ) and/or developing preventative maintenance programs.
• Basic knowledge of cGMP biomanufacturing processes and proficiency with MS Office.

Responsibilities

• Owns the lifecycle of manufacturing equipment from onboarding to decommissioning.
• Troubleshoots equipment/process failures and leads root cause investigations and CAPA.
• Designs and analyzes equipment/process experiments including scale-up/scale-down studies.
• Develops and updates operating procedures, work instructions, and change controls.
• Supports deviations, audits, and regulatory inspections as SME for equipment.

Skills

Mechanical aptitude

Troubleshooting

Equipment qualification

IQ/OQ/PQ

MS Office

Education

Bachelor's degree in engineering

Tools

MS Office

Job description

Process Engineer II - GMP Equipment Lifecycle

Seattle, WA

Process Engineer II - GMP Equipment Lifecycle

Lumen Bioscience is seeking a qualified Process Engineer who will be responsible for supporting Lumen's spirulina-based biomanufacturing platform through the lifecycle management of GMP manufacturing equipment.

Role Description:

• GMP Equipment Lifecycle:Owning the onboarding, commissioning, qualification and validation of new GMP process equipment.
• Preventative maintenance management: Development and improvement of work instructions. Establishing cleaning and sanitization procedures.
• Manufacturing Process:Partner closely with Engineering and Process Development teams to characterize and optimize manufacturing processes as it is executed on production-scale drug substance and drug product equipment.
• Team Collaboration:Work closely with manufacturing operations, Quality, and supporting teams to implement procedures, programs, and training to enhance operational efficiency and compliance.

Essential Duties and Responsibilities:

• Serve as the technical owner for manufacturing equipment through its lifecycle: coordinating pre-purchase requirements, safety assessments, training, startup change control, periodic review and eventual decommissioning.
• Troubleshoot equipment and process failures and lead root cause investigations, corrective and preventative actions (CAPA), and reliability improvements to minimize downtime and improve contamination control.
• Design, execute and analyze equipment and process-focused experiments - including optimization, scale-up and scale-down studies - to improve yield, throughput, robustness and product quality.
• Author, revise and continuously improve equipment operating procedures, work instructions, cleaning, set-up and changeover instructions, technical documentation including engineering studies and impact assessments, associated risk assessments and batch records steps to ensure safe, reproducible, compliant processes.
• Support deviations, change controls, internal and external audits and regulatory inspections as the equipment subject matter expert.

Qualifications & Requirements:

• Educational Background:Bachelor’s degree in an engineering discipline (e.g. Mechanical, Chemical, Biomedical, Industrial) required.
• Professional Experience:5+years of relevant process or equipment engineering experience, preferably in a cGMP pharmaceutical, biotechnology, or medical device manufacturing environment.
• Technical Knowledge:Strong mechanical aptitude and hands-on equipment troubleshooting experience. Experience supporting equipment qualification and validation (IQ / OQ / PQ) and/or developing preventative maintenance programs.
• Technical Skills:Basic knowledge of food, dietary supplement, biotechnology and biomanufacturing processes per cGMP (21 CFR Part 111 / 117 / 210 / 211). Proficient in Microsoft Office Suite.
• Personal Attributes:Detail-oriented, highly organized, proactive, with the ability to manage multiple tasks simultaneously in a fast-paced environment. Strong interpersonal skills and commitment to quality and ethical standards.

Physical Requirements:

• Ability to sit, stand and walk for extended periods (2+ hours) in a manufacturing or production environment.
• Occasionally lift or carry items up to 20 kg.
• Ability to gown and work in controlled and classified (cleanroom) environments and around production equipment.

Salary & Benefits at Lumen Bioscience:

• $80,000 to $110,000 salary range, depending on experience.
• Health, Dental, and Vision premiums fully covered by Lumen.
• 401k match up to 4%.
• Industry-leading PTO policy, paid refresh days, and paid year-end holiday office closure.
• Monthly wellness program to support your health and well-being.
• Free onsite parking or public transportation subsidies.
• Comprehensive parental leave policies.
• Life insurance, short & long-term disability, and access to employee assistance programs.

At Lumen Bioscience, we foster a workplace that encourages innovation, collaboration, and professional growth. This role offers an opportunity to enhance your compliance expertise while contributing significantly to advancements in biotechnology and global health solutions.

Join us and play a crucial role in ensuring manufacturing compliance and quality excellence.

Compensation Range

$80,000 - $110,000 USD

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Lumen Bioscience’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval, or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Voluntary Self-Identification of Disability

Form CC-305