Senior Validation Engineer

PSC Biotech® Corporation; Durham (NC); On-site; USD 110,000 - 145,000; Full time

Benefits offered by this job

Medical, Dental, and Vision coverage

401(k) and matching

PTO, Sick Time, Holidays

Education Assistance

Pet Insurance

Discounted Anytime Fitness rate

Financial Perks and Discounts

Job summary

PSC Biotech Corporation is seeking a Senior Validation Engineer to support commissioning, qualification, and validation of laboratory equipment, analytical instrumentation, and computerized systems in a regulated environment. You will lead validation lifecycle activities, develop protocols, manage risks, and ensure compliance with cGMP and data integrity.

You will mentor junior engineers, collaborate with cross-functional teams, and support audits and inspections to keep documentation

Qualifications

• 7+ years in validation, commissioning, qualification, or quality engineering within FDA-regulated settings.
• Experience with laboratory equipment qualification and analytical instrument validation.
• Strong CSV experience supporting regulated computerized systems.

Responsibilities

• Lead and execute commissioning, qualification, and validation activities for lab equipment, analytical instruments, utilities, and computerized systems.
• Develop, review, and execute Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, traceability matrices, and Validation Summary Reports.
• Author, execute, and review validation documentation within the KNEAT platform.
• Support Computer System Validation (CSV) activities and risk-based validation throughout lifecycle.
• Collaborate with cross-functional stakeholders to ensure on-time, compliant validation.
• Support deviation investigations, CAPAs, change controls, and impact assessments related to validation.
• Provide technical leadership and mentorship to junior validation engineers.
• Assist in internal and client audits and regulatory inspections; ensure inspection-ready documentation.

Skills

Validation

Commissioning

Qualification

Quality Engineering

CSV

KNEAT

cGMP

FDA 21 CFR 11

Technical Writing

Education

Bachelor's degree in Engineering, Life Sciences, Computer Science

Tools

KNEAT

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 seeking an experienced Senior Validation Engineer to support commissioning, qualification, and validation activities for laboratory equipment, computerized systems, and analytical instrumentation within a regulated pharmaceutical or biotechnology environment. This individual will lead validation lifecycle activities, including protocol development, execution, deviation management, and final reporting, while ensuring compliance with cGMP, data integrity, and regulatory requirements.

• Lead and execute commissioning, qualification, and validation activities for laboratory equipment, analytical instruments, utilities, and computerized systems.
• Develop, review, and execute validation deliverables including Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Validation Summary Reports.
• Author, execute, and review validation documentation within the KNEAT platform.
• Support Computer System Validation (CSV) activities.
• Perform risk assessments and apply risk-based validation methodologies throughout the system lifecycle.
• Collaborate with cross-functional stakeholders to ensure validation activities are executed on schedule and in compliance with site procedures.
• Support deviation investigations, CAPAs, change controls, and impact assessments associated with validation activities.
• Provide technical leadership and mentorship to junior validation engineers and project team members.
• Support internal audits, client audits, and regulatory inspections as needed.
• Ensure all validation documentation is complete, accurate, and inspection-ready.

Requirements

• Bachelor's degree in Engineering, Life Sciences, Computer Science, or related technical discipline.
• Minimum 7+ years of validation, commissioning, qualification, or quality engineering experience within pharmaceutical, biotechnology, medical device, or other FDA-regulated industries.
• Demonstrated experience with laboratory equipment qualification and analytical instrument validation.
• Strong Computer System Validation (CSV) experience supporting regulated computerized systems.
• Hands-on experience using KNEAT for protocol development, execution, review, approval, and lifecycle management.
• Extensive knowledge of validation lifecycle activities, including:
• Risk Assessments
• Validation Plans
• IQ/OQ/PQ Execution
• Traceability Management
• Validation Reporting
• Change Control
• Deviation Management
• Thorough understanding of cGMP regulations, FDA requirements, GAMP 5, 21 CFR Part 11, and data integrity principles.
• Strong technical writing and documentation skills.
• Ability to independently manage complex validation projects in a fast-paced environment.
• Excellent communication, stakeholder management, and cross-functional collaboration skills.
• Experience supporting regulatory inspections and audit readiness activities preferred.
• Must be authorized to work in the U.S. No C2C at this time.

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, 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

Equal Opportunity Employment Statement

PSC Biotech 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.