Validation Engineer - Pharmaceutical Sterile Manufacturing

About the job

Title of the Position: Validation Engineer

Responsibilities

• Qualification of Equipment and Systems:
• Perform or oversee the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of new and existing equipment and systems.
• Qualification of equipment in sterile manufacturing facility (e.g., aseptic processing, sterile filling, isolators, autoclave sterilization).
• Ensure compliance with regulatory requirements for equipment qualification and validation.
• Knowledge of validation equipment like Kaye validator, temperature and RH data loggers etc.
• Validation Documentation and Protocols:
• Prepare and review validation reports to ensure they 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 the 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 the development and implementation of new processes, ensuring that they are validated per regulatory requirements.
• Knowledge of cleaning validation will be an added advantage
• Perform any additional tasks as assigned by the Validations Lead

Qualifications

• 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 relevant regulatory requirements.
• Experience with equipment validation (e.g., filling machines, autoclaves, and HVAC systems) and process validation.
• Familiarity with the documentation requirements for validation, including protocol development, execution, and report writing (e.g., Excel, Validation Master Plans, LIMS systems).
• 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 willing to move to Sacramento Metropolitan Region (Approx. 40 miles’ radius)
• Willing to travel as needed basis 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

• $90,000 to $105,000
• Yearly bonus eligibility
• Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being
• Medical, dental and vision coverage
• Paid time off plan
• 401k savings plan