Validation Engineer

PSC Biotech • Gainesville, FL

2d

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 hiring a motivated Validation Engineers to join our team! This role supports Good Laboratory Practice (GLP) activities within a regulated laboratory environment. This role is responsible for executing validation and laboratory activities in compliance with FDA 21 CFR Part 58 and OECD GLP Principles, with a strong emphasis on documentation accuracy, data integrity, and inspection readiness. The Validation Engineer works closely with Study Directors, Quality Assurance, and cross‑functional scientific teams to ensure compliant study conduct and reliable nonclinical data generation.

Requirements

• Bachelor’s degree in Life Sciences, Biology, Chemistry, Biochemistry, Toxicology, or related field.
• 3–5 years of experience in GLP regulated laboratory environments. Prior experience in nonclinical laboratories, CROs, or regulated R&D organizations.
• Working knowledge of GLP regulations (FDA 21 CFR Part 58, OECD GLP Principles).
• Understanding of nonclinical study conduct and inspection‑ready laboratory practices.
• Strong documentation skills with a focus on data integrity and regulatory compliance.
• Ability to work effectively in a regulated, team‑based environment.
• Must be authorized to work in the U.S.
• No C2C at this time.

Responsibilities

• Execute and support equipment validation activities in accordance with GLP requirements, approved protocols, and SOPs.
• Perform and document equipment qualification activities (e.g., IQ/OQ/PQ) for laboratory instruments and systems used in nonclinical studies.
• Support nonclinical laboratory operations related to safety, toxicology, bioanalytical, stability, or pharmacology studies.
• Ensure proper use, maintenance, calibration, and basic troubleshooting of laboratory equipment within SOP constraints.
• Accurately document validation activities, raw data, results, and observations in controlled forms, bound notebooks, and electronic systems (e.g., LIMS/ELN).
• Adhere to Good Documentation Practices (GDP) and ALCOA/ALCOA+ data integrity principles.
• Identify and document deviations, support root cause analysis, and participate in CAPA and change control activities related to equipment or systems.
• Support QA audits, regulatory inspections, and inspection‑readiness activities related to equipment and validation documentation.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level