Sr. Validation Engineer

Nivagen Pharmaceuticals; Sacramento (CA); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Yearly bonus

Medical insurance

Dental insurance

Vision insurance

Paid time off

Job summary

Nivagen Pharmaceuticals is seeking a Sr. Validation Engineer to lead validation of processes, equipment, utilities, and systems for sterile pharmaceutical production in the Quality Assurance group.

You will develop scientifically justified validation approaches meeting cGMP and regulatory requirements, manage lifecycle projects, and mentor engineers. Reporting to the Director of Validation, you will review validation deliverables, ensure data integrity, and drive continuous improvement of

Qualifications

• Bachelor's degree or diploma in pharmaceutical sciences, engineering, life sciences, or a related technical field.
• Minimum five years of pharmaceutical validation experience, including sterile manufacturing.
• Strong working knowledge of cGMP, FDA/EMA requirements, ISO standards, validation lifecycle, and data integrity.
• Demonstrated experience leading equipment qualification and process validation projects, including protocol development and reporting.
• Experience with deviations, change controls, and supporting audits/inspections; cleaning validation experience is a plus.

Responsibilities

• Lead IQ/OQ/PQ for new and existing equipment and systems in sterile pharmaceutical production.
• Define qualification scope, test methods, acceptance criteria, and worst-case conditions.
• Develop and review validation plans, URs, risk assessments, protocols, and final reports.
• Coordinate process validation activities and support aseptic simulations with cross-functional teams.
• Mentor engineers, review documentation, and support audits/inspections.

Skills

Technical writing

Analytical skills

Troubleshooting

MS Word

MS Excel

Validation data systems

Aseptic processing

Sterile manufacturing

Education

Bachelor's degree or diploma in pharmaceutical sciences, engineering, life sciences, or related technical field

Tools

Kaye validation systems

Data loggers

Calibration instruments

Job description

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:

3900 Duckhorn Dr.

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.

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 as assigned by the Director of Validation.

Education and Experience

• Bachelor's degree or diploma in pharmaceutical sciences, engineering, life sciences, or a related technical field.
• Minimum five years of pharmaceutical validation or commissioning and qualification experience, including direct experience in sterile manufacturing.
• Strong working knowledge of cGMP, applicable FDA and EMA requirements, relevant ISO standards, validation lifecycle principles, and data integrity expectations.
• Demonstrated experience independently leading equipment qualification and process validation projects, including protocol development, execution, technical review, and final reporting.
• Experience investigating deviations, assessing change controls, and supporting audits or inspections. Cleaning validation experience is preferred.

Knowledge Skills and Abilities

• Excellent technical writing skills and the ability to communicate clear, scientifically justified conclusions.
• Strong analytical and troubleshooting skills, with attention to detail when reviewing data and complex technical documentation.
• Proficiency in Microsoft Word and Excel and familiarity with electronic systems for collecting, analyzing, and managing validation data.
• Strong understanding of aseptic processing, contamination control, and sterile manufacturing practices.

Requirements

• Must live or be willing to move to Sacramento Metropolitan Region (Approx. 40 miles’ radius)
• Willing to travel as needed to other manufacturing sites for vendor support
• Cleanroom and sterile production areas with controlled environments.
• Potential exposure to hazardous materials and chemicals used in pharmaceutical manufacturing processes.

Requirements:

• Must live or willing to move to Sacramento Metropolitan Region (Approx. 40 miles’ radius)
• Pay range $120,000-$150,000 per Year (based on experience)
• Yearly bonus eligibility
• Medical, dental and vision coverage
• Paid time off plan

Nivagen is a nicotine-free campus, meaning the use of nicotine products—including cigarettes, vaping, chewing tobacco, and any other nicotine-containing substances is strictly prohibited on company property. All employees should be able to complete their full shift without the need to use nicotine. By joining Nivagen, you agree to adhere to our nicotine-free workplace policy, which supports a healthier environment for all employees.