CSV Engineer

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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.

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 a 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.

This position will support system validation and product release processes, ensuring compliance with industry standards and regulatory requirements. You will play a key role in contributing to the development and improvement of validation procedures and driving overall product excellence. This is an entry-level, remote position. Successful candidates have a bachelor’s degree within an engineering discipline, a passion for technology, and exposure to system/software testing in the life science industry.

• Collaborate with cross‑functional teams and external clients to ensure alignment on project requirements.
• Conduct thorough testing to ensure system functionality and reliability, utilizing a risk‑based validation approach.
• Support the planning, development, and implementation of computer systems validation documentation.
• Write and execute required validation documentation including requirements specifications, test scripts, summary reports, trace matrices, etc.
• Initiate and oversee system CSV associated change control requests and associated validation documentation.
• Identify and troubleshoot any potential risks and effectively implement required solutions.
• Ensure compliance with industry standards and regulatory requirements.
• Participate in team meetings and provide updates on projects progress.
• Additional responsibilities as required.

• Bachelor's degree in a related engineering discipline.
• This is an entry‑level position. Prior internship or project experience within computer systems/software testing and validation.
• Basic understanding of validation processes and risk‑based approach.
• Familiar with clinical trial software.
• Knowledge of the Software Development Cycle is preferred.
• Excellent technical computer skills.
• Advanced technical writing skills, and familiar with technical lifecycle documentation in regulated industries.
• Strong attention to detail with a commitment to quality.
• Excellent communication and interpersonal skills.
• Excellent time management skills with the ability to manage multiple projects effectively.
• 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.

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.
• Educatio…