Process Engineer II - GMP Equipment Lifecycle

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