CSV Engineer(Computer System Validation)

About Nexinfo:

NexInfo is a consulting firm focused on improving business processes and automation in the Supply Chain and Product Lifecycle Management sectors. They offer services in business process design, software implementations, managed services, staff augmentation, and SaaS solutions. The company aims to help businesses across industries achieve their goals through industry best practices, lean process design, and advanced software solutions. Their ERP-related services address challenges such as inventory management, product lifecycle management, demand management, forecasting, sales and operations planning, business intelligence, security compliance, and financial alignment.

Hi,

Please Find the below Job Description and let me know if you are interested.

Job Title: Validation Consultant

Location: La Verne CA(Onsite)

Type: Contract

We are seeking a skilled and experienced Validation Consultant with a strong background in the pharmaceutical industry, particularly in decommissioning of facilities, equipment, and systems. The ideal candidate will work closely with cross-functional teams to ensure compliance with regulatory standards, assist in decommissioning activities, and validate systems and processes in accordance with industry best practices.

The Validation Consultant will be responsible for leading validation efforts, developing and executing validation protocols, ensuring proper decommissioning of systems, and ensuring compliance with industry regulations (e.g., FDA, EMA, ISO).

Key Responsibilities:

1. Validation Activities:

• Develop, execute, and maintain validation protocols and reports for equipment, systems, processes, and software.
• Lead qualification and validation activities for manufacturing, laboratory, and packaging systems.
• Conduct risk assessments and ensure proper risk mitigation strategies are in place.
• Provide expertise in Good Manufacturing Practice (GMP) and regulatory guidelines for validation processes.
• Perform process and equipment qualification (IQ/OQ/PQ) for new and existing systems, ensuring that they meet regulatory and quality standards.

1. Decommissioning Expertise:

• Oversee and support the decommissioning of pharmaceutical manufacturing facilities, equipment, and systems.
• Work with engineering and operations teams to assess equipment for decommissioning, ensuring compliance with environmental, health, and safety regulations.
• Develop decommissioning plans and coordinate the execution of decommissioning activities.
• Ensure that decommissioning activities are properly documented and validated according to regulatory requirements.
• Provide guidance on the appropriate disposal or repurposing of decommissioned equipment.

Thanks & Regards,

Joseph Thambi
Senior Executive - Talent Acquisition
Mob: +1

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

About Nexinfo:

NexInfo is a consulting firm focused on improving business processes and automation in the Supply Chain and Product Lifecycle Management sectors. They offer services in business process design, software implementations, managed services, staff augmentation, and SaaS solutions. The company aims to help businesses across industries achieve their goals through industry best practices, lean process design, and advanced software solutions. Their ERP-related services address challenges such as inventory management, product lifecycle management, demand management, forecasting, sales and operations planning, business intelligence, security compliance, and financial alignment.

Hi,

Please Find the below Job Description and let me know if you are interested.

Job Title: Validation Consultant

Location: La Verne CA(Onsite)

Type: Contract

We are seeking a skilled and experienced Validation Consultant with a strong background in the pharmaceutical industry, particularly in decommissioning of facilities, equipment, and systems. The ideal candidate will work closely with cross-functional teams to ensure compliance with regulatory standards, assist in decommissioning activities, and validate systems and processes in accordance with industry best practices.

The Validation Consultant will be responsible for leading validation efforts, developing and executing validation protocols, ensuring proper decommissioning of systems, and ensuring compliance with industry regulations (e.g., FDA, EMA, ISO).

Key Responsibilities:

1. Validation Activities:

• Develop, execute, and maintain validation protocols and reports for equipment, systems, processes, and software.
• Lead qualification and validation activities for manufacturing, laboratory, and packaging systems.
• Conduct risk assessments and ensure proper risk mitigation strategies are in place.
• Provide expertise in Good Manufacturing Practice (GMP) and regulatory guidelines for validation processes.
• Perform process and equipment qualification (IQ/OQ/PQ) for new and existing systems, ensuring that they meet regulatory and quality standards.

1. Decommissioning Expertise:

• Oversee and support the decommissioning of pharmaceutical manufacturing facilities, equipment, and systems.
• Work with engineering and operations teams to assess equipment for decommissioning, ensuring compliance with environmental, health, and safety regulations.
• Develop decommissioning plans and coordinate the execution of decommissioning activities.
• Ensure that decommissioning activities are properly documented and validated according to regulatory requirements.
• Provide guidance on the appropriate disposal or repurposing of decommissioned equipment.

Thanks & Regards,

Joseph Thambi
Senior Executive - Talent Acquisition
Mob: +1

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.