Sr. Validation Engineer

nivagenpharmaceuticals; United States; On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Competitive pay

Comprehensive benefits

Training & development

Job summary

Nivagen Pharmaceuticals in Sacramento, CA is seeking a Senior Validation Engineer to lead validation of processes, equipment, utilities, and systems in sterile pharmaceutical production. You will develop scientifically justified validation approaches that meet cGMP regulatory requirements and company procedures, manage projects through the validation lifecycle, and mentor engineers.

The role demands expertise in IQ/OQ/PQ, risk assessments, and robust documentation, with collaboration across

Qualifications

• Experience leading IQ/OQ/PQ protocols for new and existing equipment.
• Strong knowledge of cGMP regulatory requirements.
• Experience in sterile pharmaceutical manufacturing.
• Ability to mentor engineers and ensure technical accuracy.

Responsibilities

• Plan, write, execute, and review IQ/OQ/PQ protocols.
• Lead qualification of equipment, facilities, and utilities.
• Develop validation plans, risk assessments, and traceability matrices.
• Maintain validation records and support audits.
• Mentor validation engineers and coordinate with cross-functional teams.

Skills

Validation leadership

Quality systems

Regulatory compliance

Risk assessment

Documentation

Education

Bachelor's degree in Engineering or related field

Tools

Kaye validation systems

Job description

About the Company

Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence.

Job Location

Nivagen Pharmaceuticals Inc., Sacramento, CA

3900 Duckhorn Dr.

Sacramento, CA 95834

About the Job

Title of the Position: Sr. Validation Engineer

Department: Quality Assurance

Reports to: Director of Validation

Job Summary

The Senior Validation Engineer independently leads validation of processes, equipment, utilities, and systems supporting sterile pharmaceutical production. The role develops scientifically justified validation approaches that meet current Good Manufacturing Practices (cGMP), applicable regulatory requirements, and company procedures. Reporting to the Director of Validation, this position manages projects through the validation lifecycle, resolves complex technical issues, reviews validation deliverables, and mentor's engineers.

Responsibilities

Qualification of Equipment and Systems

Independently plan, author, execute, and technically review Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for new and existing equipment and systems.

Lead qualification of sterile manufacturing equipment, facilities, and utilities, including filling lines, isolators, autoclaves, terminal sterilizers, HVAC systems, and critical utilities.

Define qualification scope, test methods, worst-case challenge conditions, and acceptance criteria based on intended use, technical requirements, and quality risk assessments.

Perform and review thermal qualification and environmental mapping studies using Kaye validation systems, temperature and relative humidity data loggers, and calibrated test instruments.

Validation Documentation and Protocols

Author and technically review validation plans, user requirements, risk assessments, protocols, traceability matrices, and final reports, ensuring conclusions are supported by documented evidence.

Verify raw data, calculations, test results, and resolution of discrepancies before recommending completed studies for approval. Maintain accurate, complete, and traceable validation records.

Develop and improve validation procedures and templates; perform periodic reviews and define requalification requirements to maintain the validated state.

Process Validation and Cleaning Validation

Lead assigned process performance qualification activities and support aseptic process simulations in collaboration with Production, Quality Control, Quality Assurance, and technical teams.

Coordinate validation requirements for new products, process transfers, and equipment changes, including study design, sampling plans, and scientifically justified acceptance criteria.

Support the development, execution, and technical review of cleaning validation and verification studies, including worst-case selection, sampling approaches, and evaluation of results against approved limits.

Technical Leadership and Quality Systems

Manage validation projects with Engineering, Operations, Quality, and vendors; establish schedules and resource needs, resolve technical issues, and communicate progress and risks to the Director of Validation.

Lead validation-related deviation investigations, root cause analysis, impact assessments, and corrective and preventive actions (CAPA) through the site quality system.

Assess change controls and performance trends for validation impact; define required qualification, revalidation, or supporting documentation and elevate quality concerns.

Mentor validation engineers, technicians, and contractors; review their protocols and executed documentation for technical accuracy and completeness.

Support audits and regulatory inspections by preparing validation records and explaining study rationale, results, and conclusions.

Perform additional validation-related responsibilities