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.

Your Role

As a Senior CQV Engineer, you will spearhead commissioning, qualification, and validation efforts for pharmaceutical facilities, utilities, equipment, and systems. In this role, you'll take the lead in project planning, execution, and ensuring operational readiness of capital projects, contributing directly to our clients' success.

Lead validation activities in a regulated pharmaceutical environment

Oversee authoring, reviewing, and execution of validation documentation to ensure GxP compliance

Provide technical leadership and mentorship to junior engineers

Key Responsibilities:

Validation Execution & Oversight

Lead execution of validation protocols and environmental mapping

Ensure validation activities meet GMP and regulatory requirements

Troubleshoot and resolve complex validation challenges

Quality System Leadership

Oversee Change Control, Deviations, and CAPAs

Ensure timely completion of quality records and compliance with procedures

· Training & System Management

Manage Learning Management Systems (LMS) and Electronic Data Management Systems (EDMS)

Provide training and mentorship to junior engineers and new hires

Process Improvement & Strategy

Drive continuous improvement initiatives within CQV processes

Develop and implement validation strategies to enhance efficiency

Collaboration & Stakeholder Engagement

Work closely with cross-functional teams to ensure validation success

Engage with external parties to align validation efforts with industry standards

Metrics & Reporting

Track and analyze Quality System Metrics

Communicate trending data to leadership and regulatory bodies

Requirements Bachelor’s degree in Chemical Engineering, Biomedical Engineering, or related field

Minimum 7 years of experience in validation activities within GxP-regulated industries

Proven ability to lead teams and mentor/train junior engineers

Expert knowledge of cGMPs and biopharmaceutical/cell therapy regulations

Strong understanding of facility/clean room design, process, equipment, automation, and validation

Experience with start-up, validation, and licensure of new biopharmaceutical manufacturing facilities

Proven ability to work with external parties and regulatory agencies

Excellent 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

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) $110,000 – $120,000

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.

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