CSV Engineer

About the position 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 CSV engineer to support the validation and compliance of computerized systems across various business functions. This role will focus on ensuring systems meet applicable regulatory requirements and internal standards throughout their lifecycle. The position offers a hybrid work arrangement and will require regular onsite presence.

Responsibilities

• Assist with lifecycle activities for computerized systems, including planning, execution, and maintenance.
• Support validation efforts for systems used in manufacturing, quality, and other regulated operations.
• Participate in risk assessments and change control processes to maintain compliance.
• Review and approve documentation such as validation plans, protocols, and reports.
• Collaborate with internal teams and external vendors to ensure systems remain in a validated state.
• Maintain system inventories and ensure documentation is properly archived.
• Provide support during audits and inspections by preparing relevant records.
• Offer guidance on best practices for software assurance and data integrity.
• Contribute to initiatives related to electronic records and signatures compliance.
• Perform other duties as needed to support organizational objectives.

Requirements

• Bachelor’s degree in a technical or life sciences discipline.
• 5+ years of experience in computer system validation or software assurance within regulated industries.
• Familiarity with regulatory frameworks and standards such as FDA, ISO, and GAMP guidelines.
• Experience with MES (Manufacturing Execution Systems) is required.
• Hands -on experience with validation documentation and system lifecycle processes.
• Knowledge of both on -premises and cloud -based applications.

Nice-to-haves

• Experience with quality management systems or similar platforms is preferred.

Benefits

• 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

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