Validation - OQSIE
McPherson, KS
About the Job
McPherson Validation Resource Review
1. Request ID: (two resources): Position Comments visible to MSP and Supplier: Experience with packaging qualification and packaging vision systems required.
a. Job Description: General Tasks: Small project execution. Troubleshooting/commissioning/validation. General Operations Support. Documentation generation (specifications, protocols, etc) Support of maintenance of operation equipment. General requirements: BS or MS degree in engineering or other scientific background. Should be familiar with biopharmaceutical equipment (bioreactors, ultrafiltration systems, etc) if possible and must have good GMP knowledge. Work well independently as well as in a team. Years of Experience 5-10
b.
2. Request ID: (eight resources): Position Comments visible to MSP and Supplier: Experience with packaging qualification and packaging vision systems required.
a. Job Description: General Tasks: Small project execution. Troubleshooting/commissioning/validation. General Operations Support. Documentation generation (specifications, protocols, etc) Support of maintenance of operation equipment. General requirements: BS or MS degree in engineering or other scientific background. Should be familiar with biopharmaceutical equipment (bioreactors, ultrafiltration systems, etc) if possible and must have good GMP knowledge. Work well independently as well as in a team. Years of
3. Request ID: (Two Resorces)
Responsibilities:
Reporting to the Validation Section Manager, the Validation Engineer will assure that computerized systems are validated in accordance with cGMP principles, regulatory requirements, and company policies and standards. The Validation Engineer will be required to become a subject matter expert (SME) in Computer System Validation (CSV), provide technical expertise and guidance to management and cross functions. The Validation Engineer will manage the validation of new systems, as well as changes to existing systems, and will work closely with cross functions (laboratory, production, engineering, automation, quality, and BT) to ensure that CSV requirements are met.
Role Responsibilities
• Support all aspects of Computer System Validation projects
• Author, execute, or review CSV documents: Validation Project Plans, User and Functional Requirements, Design Specifications, Risk Management tools, GxP and Electronic Records (ER) / Electronic Signature (ES) assessments, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) protocols, Enhanced Design Reviews, Final Reports, and Deviation Handling
• Manage and execute decommissioning activities
• Ability to work collaboratively with cross functions within the organization
• Represent Validation in cross functional team meetings or projects as required
• Perform job responsibilities in compliance with cGMP, regulatory requirements, company policies and standards
Qualifications
• Experience in a cGMP environment
• Direct computer system validation experience
• Strong understanding of GAMP 5 Risk Based approaches, GMPs, Data Integrity, 21 CFR Part 11 and Annex 11 regulations (Electronic Records and Electronic Signatures), guidance for software IQ/OQ/PQ and Standard Operating Procedures
• Ability to work independently with limited managerial oversight
• Bachelor's degree in Engineering, Science, or related field
• Good written and oral communication skills
1. Request ID: (two resources): Position Comments visible to MSP and Supplier: Experience with packaging qualification and packaging vision systems required.
a. Job Description: General Tasks: Small project execution. Troubleshooting/commissioning/validation. General Operations Support. Documentation generation (specifications, protocols, etc) Support of maintenance of operation equipment. General requirements: BS or MS degree in engineering or other scientific background. Should be familiar with biopharmaceutical equipment (bioreactors, ultrafiltration systems, etc) if possible and must have good GMP knowledge. Work well independently as well as in a team. Years of Experience 5-10
b.
2. Request ID: (eight resources): Position Comments visible to MSP and Supplier: Experience with packaging qualification and packaging vision systems required.
a. Job Description: General Tasks: Small project execution. Troubleshooting/commissioning/validation. General Operations Support. Documentation generation (specifications, protocols, etc) Support of maintenance of operation equipment. General requirements: BS or MS degree in engineering or other scientific background. Should be familiar with biopharmaceutical equipment (bioreactors, ultrafiltration systems, etc) if possible and must have good GMP knowledge. Work well independently as well as in a team. Years of
3. Request ID: (Two Resorces)
Responsibilities:
Reporting to the Validation Section Manager, the Validation Engineer will assure that computerized systems are validated in accordance with cGMP principles, regulatory requirements, and company policies and standards. The Validation Engineer will be required to become a subject matter expert (SME) in Computer System Validation (CSV), provide technical expertise and guidance to management and cross functions. The Validation Engineer will manage the validation of new systems, as well as changes to existing systems, and will work closely with cross functions (laboratory, production, engineering, automation, quality, and BT) to ensure that CSV requirements are met.
Role Responsibilities
• Support all aspects of Computer System Validation projects
• Author, execute, or review CSV documents: Validation Project Plans, User and Functional Requirements, Design Specifications, Risk Management tools, GxP and Electronic Records (ER) / Electronic Signature (ES) assessments, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) protocols, Enhanced Design Reviews, Final Reports, and Deviation Handling
• Manage and execute decommissioning activities
• Ability to work collaboratively with cross functions within the organization
• Represent Validation in cross functional team meetings or projects as required
• Perform job responsibilities in compliance with cGMP, regulatory requirements, company policies and standards
Qualifications
• Experience in a cGMP environment
• Direct computer system validation experience
• Strong understanding of GAMP 5 Risk Based approaches, GMPs, Data Integrity, 21 CFR Part 11 and Annex 11 regulations (Electronic Records and Electronic Signatures), guidance for software IQ/OQ/PQ and Standard Operating Procedures
• Ability to work independently with limited managerial oversight
• Bachelor's degree in Engineering, Science, or related field
• Good written and oral communication skills
Source : OQSIE
