CQV Engineer
New Yesterday
PSC Biotech provides the life sciences with essentialservices 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.
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,
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
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) $85,000 – $100,000
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.
#LI-RD1
- Location:
- Seattle
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