Sterile Pharma Validation Engineer

Nivagen Pharmaceuticals Inc; Sacramento (CA); On-site; USD 90,000 - 105,000; Full time

Benefits offered by this job

Yearly bonus eligibility

Medical, dental and vision coverage

Paid time off

401k savings plan

Job summary

Nivagen Pharmaceuticals LLC in Sacramento seeks a Validation Engineer to ensure sterile manufacturing processes and related equipment meet cGMP and regulatory standards (FDA/EMA/ISO).

You will drive IQ/OQ/PQ activities, prepare validation documentation, and work with cross-functional teams to validate processes and cleaning methods. Strong writing and regulatory knowledge are essential.

Qualifications

• Bachelor's or Diploma in Pharmaceuticals or related field.
• 2+ years in pharmaceutical manufacturing or validation, focusing on sterile processes.
• Strong understanding of cGMP, FDA, EMA, ISO standards.
• Experience with equipment validation and process validation.
• Familiarity with validation documentation, protocol development and reporting.

Responsibilities

• Perform IQ, OQ, PQ for new and existing equipment and systems.
• Validate aseptic equipment like filling machines, isolators, autoclaves.
• Ensure regulatory compliance for qualification and validation.
• Prepare and review validation reports per regulatory and company requirements.
• Maintain validation records and traceability of activities.
• Conduct process and cleaning validation; collaborate with cross-functional teams.
• Support development and implementation of new validated processes.
• Knowledge of cleaning validation is a plus.
• Assist Validations Lead with additional tasks.

Skills

Technical writing

Attention to detail

Cross-functional work

Data analysis tools

Aseptic processing

Education

Bachelor/ Diploma in Pharmaceuticals

Tools

LIMS

Kaye validator

Job description

Nivagen Pharmaceuticals LLC in Sacramento seeks a Validation Engineer to ensure sterile manufacturing processes and related equipment meet cGMP and regulatory standards (FDA/EMA/ISO).

You will drive IQ/OQ/PQ activities, prepare validation documentation, and work with cross-functional teams to validate processes and cleaning methods. Strong writing and regulatory knowledge are essential.