CQV Engineer

The Experience

At PSC Biotech it s about more than just a job it s about your career and your future.

Your Role

As a Junior CQV Engineer you will support commissioning qualification and validation (CQV) efforts for pharmaceutical facilities utilities equipment and systems. In this role youll 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
  

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

Benefits

Offering a full suite of benefits PSC Biotech is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance so you not only enjoy your work but also have the time and resources to live your life happy and healthy.

• Medical Dental and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
  
• Insurance options for Employee Assistance Programs Basic Life Insurance Short/Long Term Disability and more.
  
• 401(k) and 401(k) matching
  
• PTO Sick Time and Paid Holidays
  
• Education Assistance
  
• Pet Insurance
  
• Discounted rate at Anytime Fitness
  
• Financial Perks and Discounts
  
• Estimated annual salary (dependent on experience) $85000 $100000
  

Equal Opportunity Employment Statement:

PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees interns and applicants for employment. Consistent with this commitment our policy is to comply with all applicable federal state and local laws concerning employment discrimination. Accordingly the Company prohibits discrimination against qualified employees interns and applicants in all aspects of employment including but not limited to: recruitment interviewing hiring (or failure or refusal to hire) evaluation compensation promotion job assignment transfer demotion training leaves of absence layoff benefits use of facilities working conditions termination and employer-sponsored activities and programs including wellness social and recreational programs. Employment decisions will be made without regard to an applicant s employee s or intern s actual or perceived: race color religion sex (including pregnancy gender identity and sexual orientation) national origin age (40 or older) disability genetic information or any other status protected by law.

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