VHP Sterilization Specialist - GMP Validation Expert

Stark Pharma Solutions Inc; Indianapolis (IN); Sur place; USD 75 000 - 110 000; Plein temps

Résumé du poste

Stark Pharma Solutions Inc. in Indiana seeks an experienced VHP Sterilization Specialist to support sterilization and decontamination activities within a GMP-regulated pharmaceutical facility. You will focus on VHP cycle development, qualification, validation, troubleshooting, and documentation.

The role requires hands-on technical expertise in sterilization processes, documentation, and cross-functional collaboration with Quality, Engineering, Manufacturing, and Validation teams.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Microbiology, or a related field.
• Experience with VHP sterilization or bio-decontamination in pharmaceutical or biotech environments.
• Strong knowledge of GMP, sterilization validation, cycle development, and qualification.
• Experience with IQ/OQ/PQ and Deviation/CAPA processes is preferred.
• Experience with sterilization cycle data and validation documentation.
• Strong technical documentation and troubleshooting skills.
• Excellent communication and cross-functional collaboration skills.

Responsabilités

• Support VHP sterilization and bio-decontamination processes for pharmaceutical manufacturing areas and equipment.
• Develop, execute, and document VHP cycle qualification and validation activities.
• Support cycle development, optimization, and performance qualification.
• Review sterilization parameters, biological/chemical indicators, and cycle data.
• Troubleshoot cycle failures, deviations, and process-related issues.
• Prepare and review protocols, reports, SOPs, and validation documentation.
• Ensure compliance with GMP, FDA, GAMP 5, and company procedures.

Connaissances

GMP knowledge

Cycle development

Validation documentation

Cross-functional collaboration

Technical communication

Formation

Bachelor's degree in Engineering, Life Sciences, Microbiology, or related field

Outils

IQ/OQ/PQ processes

Description du poste

Stark Pharma Solutions Inc. in Indiana seeks an experienced VHP Sterilization Specialist to support sterilization and decontamination activities within a GMP-regulated pharmaceutical facility. You will focus on VHP cycle development, qualification, validation, troubleshooting, and documentation.

The role requires hands-on technical expertise in sterilization processes, documentation, and cross-functional collaboration with Quality, Engineering, Manufacturing, and Validation teams.