# Process Engineer II - GMP Equipment Lifecycle at Lumen Bioscience

Process Engineer II - GMP Equipment Lifecycle at Lumen Bioscience in Seattle, WA. On-site, paying $80k–$110k. Posted August 27, 2026.

- Company: Lumen Bioscience
- Location: Seattle, WA
- Workplace: On-site
- Pay: $80k–$110k
- Experience: 5+ years
- Posted: 2026-08-27
- Apply: https://job-boards.greenhouse.io/lumenbioscience/jobs/4385376009
- Source: https://jobmagic.ai/jobs/process-engineer-ii-gmp-equipment-lifecycle-lumen-bioscience-yc0qm0

## 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.

## Description

**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