Validation Engineer - Pharmaceutical Sterile Manufacturing

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. We pursue excellence, integrity, and respect for people, with a focus on manufacturing, distribution, and quality control. We invest in our workforce through competitive pay, comprehensive benefits, and training opportunities to drive innovation and improve healthcare accessibility and affordability.

Nivagen Pharmaceuticals Inc., Sacramento, CA
3900 Duckhorn Dr, Sacramento, CA 95834

Title of the Position:
Validation Engineer

As a Validation Engineer, you will ensure that manufacturing processes, equipment, utilities, and systems in the sterile pharmaceutical production environment meet regulatory requirements, industry standards, and company specifications. You will support the validation lifecycle from installation through qualification and routine re-validation activities, ensuring compliance with cGMP and regulatory guidelines (FDA, EMA, ISO).

• Qualification of Equipment and Systems:
• Perform or oversee Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of new and existing equipment and systems
• Qualification of equipment in sterile manufacturing facilities (e.g., aseptic processing, sterile filling, isolators, autoclave sterilization)
• Ensure compliance with regulatory requirements for equipment qualification and validation
• Knowledge of validation equipment such as Kaye validator, temperature and RH data loggers
• Validation Documentation and Protocols:
• Prepare and review validation reports to meet regulatory and company requirements
• Maintain traceability of validation activities and ensure all validation records are accurately documented, maintained, and stored
• Process Validation and Cleaning Validation:
• Conduct and manage process validation studies to confirm sterility and quality of pharmaceutical products
• Work with cross-functional teams (e.g., production, quality control, engineering) to optimize manufacturing processes and ensure consistency and repeatability
• Support development and implementation of new processes and ensure they are validated per regulatory requirements
• Knowledge of cleaning validation is an added advantage
• Perform any additional tasks as assigned by the Validations Lead

Education/

Experience:

• Bachelor's degree or Diploma in Pharmaceuticals or a related field
• Minimum 2 years of experience in a pharmaceutical manufacturing or validation role, with a focus on sterile manufacturing (e.g., aseptic processing, sterile filling, isolator, autoclave sterilization)
• Strong understanding of cGMP, FDA, EMA, ISO standards, and other regulatory requirements
• Experience with equipment validation (e.g., filling machines, autoclaves, HVAC systems) and process validation
• Familiarity with validation documentation requirements, including protocol development, execution, and report writing

Knowledge, Skills, and Abilities:

• Excellent technical writing and documentation skills
• Strong attention to detail and ability to manage complex technical documentation
• Ability to work cross-functionally and manage multiple priorities
• Familiarity with data analysis tools and software used for validation testing and reporting (e.g., Excel, Validation Master Plans, LIMS systems)
• Aseptic processing or sterile manufacturing practices

Requirements:

• Must live or be willing to move to the 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

Benefits:

• Competitive salary
• Yearly bonus eligibility
• Medical, dental and vision coverage
• Paid time off plan
• 401(k) savings plan

Additional Information:

Nivagen is an equal opportunity employer and prohibits discrimination or harassment based on race, color, age, national origin, disability, religion, gender, gender identity, sexual orientation, veteran status, or any other characteristic protected by law.