Sterile Validation Engineer – cGMP Compliance Lead

Nivagen Pharmaceuticals; Sacramento (CA); Sur place; USD 90 000 - 110 000; Plein temps

Avantages offerts par ce poste

Medical, dental and vision coverage

Paid time off

Employee training and development

Résumé du poste

Nivagen Pharmaceuticals is seeking a Validation Engineer for its Sacramento sterile manufacturing operations. You will oversee IQ/OQ/PQ activities and ensure aseptic processes comply with cGMP, FDA, EMA, and ISO standards.

Work will involve cross-functional collaboration with production, quality control, and engineering to validate equipment, systems, and cleaning processes, and to prepare robust validation documentation.

Qualifications

• Bachelor's degree or Diploma in Pharmaceuticals or related field.
• Minimum 2 years in pharma manufacturing or validation, sterile focus.
• Strong understanding of cGMP, FDA, EMA, ISO standards.

Responsabilités

• Perform IQ/OQ/PQ for new and existing equipment and systems.
• Validate sterile manufacturing equipment and processes (aseptic, isolators, autoclave).
• Prepare and review validation reports and maintain traceability of activities.
• Collaborate with production, quality control, and engineering to optimize processes.
• Assist with cleaning validation and development of new validated processes.

Connaissances

Sterile manufacturing

Technical writing

Attention to detail

Cross-functional collaboration

Formation

Bachelor's degree in Pharmaceuticals

Outils

Excel

LIMS

Kaye validator

Description du poste

Nivagen Pharmaceuticals is seeking a Validation Engineer for its Sacramento sterile manufacturing operations. You will oversee IQ/OQ/PQ activities and ensure aseptic processes comply with cGMP, FDA, EMA, and ISO standards.

Work will involve cross-functional collaboration with production, quality control, and engineering to validate equipment, systems, and cleaning processes, and to prepare robust validation documentation.