VHP Sterilization Specialist

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

About The Company

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Position: VHP Sterilization Specialist

Location: Indiana, USA

Duration: Long Term

Job Overview

We are seeking an experienced VHP Sterilization Specialist to support sterilization and decontamination activities within a GMP-regulated pharmaceutical manufacturing environment. The role will focus on VHP cycle development, qualification, validation, troubleshooting, and documentation.

Key Responsibilities

• 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.
• Collaborate with Quality, Engineering, Manufacturing, Validation, and Automation teams.

Required Qualifications

• Bachelor s degree in Engineering, Life Sciences, Microbiology, or a related field.
• Experience with VHP/H O 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.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.