Commissioning, Qualification, Validation Engineer (CQV)

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 to form something truly special.

When you decide 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

We are hiring experienced CQV Engineers (different levels) to support the commissioning, qualification, and validation for a range of equipment and systems within the pharmaceutical and / or biotechnology industry, preferably experience working within cell and gene therapeutics and clean room environments.

• Lead the development and execution of commissioning, qualification, and validation protocols for a range of equipment and systems.
• Draft, review, author, and deploy all required validation documentation including IQ / OQ / PQ protocols, reports, master plans, risk assessments, procedures, reports, URS, FRS, and so on.
• Provide technical expertise throughout the validation lifecycle including risk assessment, deviation investigation, and change control activities.
• Support environmental monitoring tasks as required.
• Effectively identify potential risks and areas of improvement and proactively implement risk mitigation.
• Document test results, deviations, and investigations in compliance with company procedures and regulatory standards.
• Collaborate with cross functional teams to support all project timelines and deliverables and be able to drive successful validation of critical systems and equipment.
• Contribute to the continuous improvement of validation processes, procedures and projects.
• Lead / Manage projects from initiation to completion, ensuring compliance with regulatory requirements and company standards.
• Ensure compliance with industry regulations and requirements at all times.
• Additional responsibilities as required.

Requirements

• Bachelor's degree in related engineering discipline.
• 5 years or more of experience executing commissioning, qualification, and validation for a range of Lab equipment within the pharmaceutical and / or biotechnology industries.
• Knowledge of cell and gene therapy.
• Validation experience supporting clean room environmental monitoring (EM) qualification.
• Knowledge of regulatory requirements (cGMP, FDA, etc.).
• Project Management experience or certification.
• Excellent problem-solving, analytical, and technical skills. Ability to problem-solve and troubleshoot effectively.
• Strong time management and organizational abilities.
• Effective communication and interpersonal skills.
• Detail-oriented mindset with a commitment to maintaining high-quality standards.
• Ability to work independently and as part of a team.

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 Holiday
• Education Assistance
• Pet Insurance
• Discounted Fitness / Gym Rates
• Financial Perks and Discounts

Adhering to the requirements of California's law on salary transparency, the salary bracket for this role is set between $100,000 - $150,000 annually.

The offered salary may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.

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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Requirements

Bachelor's degree in related engineering discipline. 5 years or more of experience executing commissioning, qualification, and validation for a range of equipment within the pharmaceutical and / or medical device industries.

Knowledge of regulatory requirements (cGMP, FDA, etc.). Excellent problem-solving, analytical, and technical skills. Ability to problem-solve and troubleshoot effectively.

Strong time management and organizational abilities. Effective communication and interpersonal skills. Detail-oriented mindset with a commitment to maintaining high-quality standards.

Ability to work independently and as part of a team.