JOB INFORMATION

Date Opened
06/10/2025
Job Type
Full time
Work Experience
3-7 years
Industry
Biotechnology
City
Seattle
State/Province
Washington
Country
United States

JOB DESCRIPTION

PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.
Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.

THE EXPERIENCE

With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.
We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.
At PSC Biotech®, it’s about more than just a job—it’s about your career and your future.

REQUIREMENTS

• Bachelor’s degree in Chemical Engineering, Biomedical Engineering, or related field
• Minimum 3 years of experience in validation activities within GxP-regulated industries
• Expert knowledge of cGMPs and biopharmaceutical/cell therapy regulations
• Understanding of facility/clean room design, process, equipment, automation, and validation
• Experience with start-up, validation, and licensure of new biopharmaceutical manufacturing facilities
• Strong verbal and written communication skills with the ability to influence at all levels
• Ability to prioritize tasks and provide clear direction in a dynamic environment
• Proficiency in MS Office Applications and ability to quickly learn new software programs
• Experience working with external parties in a regulated industry
• Positive personality and solution-driven mindset
• Ability to excel in a fast-paced environment
• Must live in the Seattle area and be willing to work fully onsite

As a Junior CQV Engineer, you will support commissioning, qualification, and validation (CQV) efforts for pharmaceutical facilities, utilities, equipment, and systems. In this role, you’ll assist in executing validation protocols, documenting results, and ensuring compliance with GMP regulations. You will work closely with senior engineers to learn industry best practices, contribute to quality system improvements, and help maintain operational readiness for capital projects. This position is ideal for someone looking to develop expertise in pharmaceutical validation while gaining hands-on experience in a regulated environment.

Key Responsibilities:

• Validation Execution
• Support execution of validation protocols and environmental mapping
• Accurately document results under supervision
• Ensure records meet GMP and regulatory requirements
• Quality System Support
• Assist in Change Control, Deviations, and CAPAs
• Perform periodic document reviews
• Training & System Management
• Help manage Learning Management Systems (LMS) and Electronic Data Management Systems (EDMS)
• Provide onboarding training for new hires
• Process Improvement
• Participate in continuous improvement initiatives within CQV processes
• Collaboration & Support
• Work closely with senior engineers to assist in CQV activities
• Support validation system updates and impact assessments
• Work with external parties to ensure compliance and project success
• Metrics & Reporting
• Track and analyze Quality System Metrics
• Report trending data to leadership