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Nivagen Pharmaceuticals

Sr. Validation Engineer

Sacramento, CA, United States
Pittsburg, CA, United States

$120,000 to $150,000 USD / year

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Job details

Pay: $120,000 to $150,000 USD / year
Posting language: English
Posted: Nov 20, 2024

Original 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 escalate 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

Work Environment

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)

Benefits:

Pay range $120,000-$150,000 per Year (based on experience)
Yearly bonus eligibility
Medical, dental and vision coverage
Paid time off plan

Additional Information:

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.

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