Validation Technician

Validation Technician 

The Validation Technician supports the qualification and validation activities required to maintain compliance within a 503B outsourcing facility. This role is responsible for executing validation protocols, performing routine equipment and facility qualification/requalification, and documenting results in accordance with regulatory standards. The Validation Technician will work closely with Quality, Engineering, and Operations teams to ensure processes, equipment, and systems are compliant, reliable, and inspection-ready.

Why Join Leiters Health? 

Are you passionate about making a real impact in the pharmaceutical industry? Do you thrive in a collaborative, innovative environment where your skills and ideas are valued? Look no further – Leiters Health is seeking talented individuals like you to join our dynamic team! 

At Leiters Health, we're not just another pharmaceutical company – we're pioneers in the field, dedicated to delivering high-quality compounded sterile products and outsourced solutions to healthcare providers nationwide. Our commitment to excellence and patient safety is at the core of everything we do. 

• Innovative Culture: Be part of a forward-thinking company that encourages creativity, welcomes fresh ideas, and fosters an environment of continuous improvement.
• Meaningful Work: Contribute to a purpose-driven organization dedicated to providing critical medications and healthcare solutions that positively impact patients' lives.
• Professional Development: Access ongoing training, mentorship, and growth opportunities to expand your skills and advance your career within a rapidly growing industry.
• Cutting-Edge Technology: Work with state-of-the-art facilities and advanced technologies, staying ahead of the curve in pharmaceutical manufacturing.
• Collaborative Environment: Join a team of passionate individuals who are dedicated to teamwork, support, and mutual success, fostering a culture of inclusivity and collaboration.

Who We're Looking For: 

We're seeking enthusiastic individuals who are driven, adaptable, and passionate about contributing to a mission-driven organization. Whether you're an experienced professional or just starting your career, Leiters Health provides an environment where your skills and talents will be recognized and appreciated. Sound like you? Apply today! 

Key Responsibilities:

Validation & Qualification

• Execute validation and qualification protocols for equipment, utilities, facilities, and processes (IQ/OQ/PQ).
• Perform routine requalification activities to ensure continued compliance with regulatory standards.
• Support routine re-qualification activities.
• Assist with data collection, sampling, and analysis for validation studies.

Documentation & Compliance

• Accurately complete validation records, test logs, and reports in alignment with cGMP requirements.
• Ensure all protocols, discrepancies, and final reports are documented, reviewed, and archived per SOPs.
• Participate in investigations, CAPAs, and audits as needed.

Cross-Functional Support

• Collaborate with Quality Assurance, Engineering, and Operations to support validation schedules and project timelines.
• Assist in the evaluation of new equipment and processes for validation requirements.
• Support the implementation of best practices, new technologies, and process improvements.

Qualifications:

• Associate or Bachelor’s degree in Engineering, Life Sciences, or related technical field preferred; equivalent relevant experience considered.
• 2 years of validation, quality, or technical experience in pharmaceutical, biotech, or compounding operations (503B experience strongly preferred).
• Working knowledge of Pharmaceutical regulation, cGMP, and aseptic techniques.
• Familiarity with validation protocols (IQ/OQ/PQ), cleaning validation, and sterilization validation.
• Strong documentation, analytical, and organizational skills.
• Ability to work in a cleanroom environment and adhere to gowning/aseptic practices.

Benefits: 

• 100% employer paid medical plan.
• Dental & Vision insurance options including FSA & HSA
• Employer Paid Life Insurance & Employee Assistance Program
• Short Term & Long-Term Disability Insurance
• Up to 4% 401K Matching (100% vested on day one!)
• Generous Paid Time Off Options – vacation, sick, paid leave and holidays!
• $5,250 Annual Tuition Reimbursement after 6 months
• $1,000 Referral Bonus Program with no limit
• Eligible for annual bonus program 

Timeline: We will be accepting applications on an ongoing basis until position is filled.  

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. 

*Please note that we do not work with third-party recruiters or agencies for this position. If you are a qualified candidate and wish to apply for this job, please do so directly through our official application process. We appreciate your understanding and cooperation in this matter.