CSV Engineer

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 seeking an experienced and highly skilled Senior Computer System Validation (CSV) Engineer to join our team. The CSV Engineer will provide guidance and support in the validation of computer systems used in the pharmaceutical, biotechnology, or medical device industries. The ideal candidate will have an in-depth knowledge of CSV principles, excellent problem-solving abilities, and a strong track record of successful project delivery.

• Develop and implement CSV strategies, methodologies, and processes and approve project deliverables.
• Collaborate closely with clients and cross-functional teams to ensure compliance with regulatory requirements and industry best practices. Maintain computerized system compliance at all times.
• Conduct risk assessments and define validation requirements based on industry standards and regulatory guidelines. Ensure validation risk management process is accurately and efficiently documented, including vendor qualifications.
• Develop and review validation documentation, such as validation plans, protocols, reports, and standard operating procedures (SOPs).
• Perform gap assessments and identify areas for improvement in CSV practices.
• Ensure the implementation of change management processes for operational computerized systems.
• Develop global training for compliance concerning electronic record regulations and standards.
• Lead the periodic review process and master validation plans.
• Oversee and maintain system inventory.
• Participate in regulatory inspections and audits, providing expertise and support during inspections.
• Conduct regular project status updates, communicate project risks, and propose mitigation strategies to relevant project stakeholders.
• Stay up-to-date with regulatory requirements, industry trends, and best practices related to computer system validation.
• Interpret and apply regulations (e.g., FDA, EMA, ICH) and guidelines (e.g., GAMP) to ensure compliance.
• Additional duties as assigned.

Requirements

• Bachelor's Degree in Engineering.
• 10+ years of experience in computer system validation within the pharmaceutical, biotechnology, or medical device industries.
• Extensive knowledge of regulatory requirements.
• Strong understanding of validation methodologies, risk management, and industry quality/compliance.
• Excellent problem-solving, analytical thinking, and attention to detail.
• Ability to prioritize and manage multiple projects simultaneously.
• Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and stakeholders at various levels of the organization.
• Detail-oriented and quality-focused mindset, with a commitment to ensuring compliance and delivering high-quality results.
• Experience with clinical systems is preferred.
• Experience with DSVP system is a plus.
• Experience with Veeva deployment is a plus.
• Experience with system deployment to ISO standards is a plus.
• 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
• Discounted rate at Anytime Fitness
• Financial Perks and Discounts

Estimated Annual Salary (dependent on experience): $95,000 - $127,500

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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