CQV Engineer

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.

Your Role

We are hiring an experienced CQV Engineer to join our team. The successful candidate will have a strong understanding of pharmaceutical manufacturing processes, regulatory requirements, and validation principles.

• Plan, execute, and document requalification activities for facilities, systems, and equipment.
• Develop and update requalification protocols (IQ/OQ/PQ) in compliance with GMP, FDA, and other regulatory requirements.
• Perform periodic reviews and requalification assessments to ensure ongoing compliance.
• Lead commissioning and qualification efforts for new and existing systems.
• Troubleshoot and resolve issues identified during CQV activities.
• Collaborate with cross functional teams to gather requirements and align on project timelines and deliverables.
• Prepare detailed validation documentation, including protocols, reports, deviations, and change controls.
• Ensure all validation activities are documented accurately and comply with regulatory requirements.
• Maintain up-to-date knowledge of industry trends, regulatory changes, and best practices in CQV.
• Contribute to the continuous improvement of validation processes and procedures.
• Ensure compliance with industry regulations and requirements at all times.
• Additional responsibilities as required.

Requirements

• Bachelor's degree in related engineering discipline.
• 5-7+ years of CQV engineering experience in the pharmaceutical industry.
• In-depth knowledge of regulatory requirements and industry standards (GMP, FDA, ISO, etc.)
• Demonstrated experience in requalification of pharmaceutical systems and equipment.
• Excellent analytical, problem-solving, and technical writing skills.
• Proficient in developing and executing IQ/OQ/PQ protocols.
• Effective communication and interpersonal skills, with the ability to work collaboratively in a team environment.
• At PSC Biotech, many of our projects and clients are located in various regions around the country. Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations, cultures, and work environments is essential, as it allows our team members to collaborate effectively with clients and colleagues nationally.

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
• Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more).
• Financial Perks and Discounts

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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