Planet Pharma
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https://www.propharmagroup.com
https://www.propharmagroup.com
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Software Validation QA Engineer
2000 Hollister Drive Libertyville, IL 60048 US
Posted: 05/06/2024
2024-05-06
2024-08-25
Employment Type:
Contract
Job Category: Engineering
Job Number: 605889
Is job remote?: No
Country: United States
Job Description
SUMMARY
The primary purpose of the Software Validation Engineer – Contingent Worker role is to support delivery of global software validation projects in collaboration with IT and system owner cross functional teams. This role represents the quality (GQRA) function for the software project to ensure compliance with global software procedures, software standards, and regulations with regards to validation and documentation controls. The position has direct involvement with the introduction and maintenance of global software systems utilized to support GMP manufacturing.
Reporting to the Global Validation Manager, this role is responsible for being the quality representative for computer system validations, development and execution of validation plans, protocols, and testing
documentation for compliant computerized operations in a GMP environment. The role will support the establishment of standard work practices and testing for the validation and ongoing maintenance of
computerized systems and will support investigations, resolve potential data integrity issues, and implement process improvements to mitigate any risks to the validated state.
RESPONSIBILITIES • Ensure all Computerized system applications are qualified in compliance with company policies and procedures, FDA, European cGMP, and GAMP standards
• Co-ordinate, provide guidance and actively participate as a project team member for software validation projects
• Generation/maintenance of software validation plans, protocols, and reports to cGMP standard
• Review / approval of software validation plans, requirements, protocols/ test scripts and final reports
• Management of software validation change control process.
• Serve as validation SME providing guidance and direction to lead validation activities for software projects
• Represent validation team at both internal and external audits and at Quality System Management Reviews when applicable
• Responsible for the overall administration of the document control program related to software validation
ESSENTIAL FUNCTIONS OF THE ROLE • Strong communication skills both verbal and written
• A high level of attention to detail, to ensure accuracy and full compliance with procedures
• Strong work ethic and an ethos of Right-First-Time
• Total commitment to quality and maintaining a high standard of work at all times
• Strong interpersonal skills
• Strong leadership skills with the ability to influence change when needed
• Good project management skills including organization and planning
• Ability to work independently and remotely with minimum direct supervision WORK EXPERIENCE REQUIREMENTS • Number of Overall Years Necessary: 2-5
• Experience working with computer systems, software validation, or related field is essential
• Computer Systems Validation experience and understanding of applicable regulations (Annex 11, GAMP, 21 CFR Part 11)
• Regulated environment, medical devices experience is preferable
• Previous people management (direct or indirect) experience is preferable
EDUCATION REQUIREMENTS
• Bachelor’s Degree in a scientific or engineering discipline required
• Advanced Degree desired SPECIALIZED SKILLS / TECHNICAL KNOWLEDGE • Good knowledge and understanding of the medical device quality and regulatory requirements, including ISO13485, GAMP 5, IEC62304, 21CFRpart 820, part 11 as well as other Computer System Validation processes
• Demonstrated working knowledge in the principles and effective implementation of software validation methodology
• Experience in the review, evaluation and testing of systems to ensure compliance with FDA Electronic Records/Electronic Signatures regulations
• Good overall knowledge with IT infrastructure and applications
• Experience of testing GAMP Category 3, 4 & 5 systems
• Strong oral, written communication, and interpersonal skills
• Ability to work closely with people at all levels of the organization and with persons from different cultural, language and regional backgrounds to accomplish assigned project goals
• Must be results driven striving to meet all targets and prioritize/manage project deliverables
• Experience interacting with auditors preferred
Pay Rate Range: $40-55/hr. Salary will be commensurate with experience
The primary purpose of the Software Validation Engineer – Contingent Worker role is to support delivery of global software validation projects in collaboration with IT and system owner cross functional teams. This role represents the quality (GQRA) function for the software project to ensure compliance with global software procedures, software standards, and regulations with regards to validation and documentation controls. The position has direct involvement with the introduction and maintenance of global software systems utilized to support GMP manufacturing.
Reporting to the Global Validation Manager, this role is responsible for being the quality representative for computer system validations, development and execution of validation plans, protocols, and testing
documentation for compliant computerized operations in a GMP environment. The role will support the establishment of standard work practices and testing for the validation and ongoing maintenance of
computerized systems and will support investigations, resolve potential data integrity issues, and implement process improvements to mitigate any risks to the validated state.
RESPONSIBILITIES • Ensure all Computerized system applications are qualified in compliance with company policies and procedures, FDA, European cGMP, and GAMP standards
• Co-ordinate, provide guidance and actively participate as a project team member for software validation projects
• Generation/maintenance of software validation plans, protocols, and reports to cGMP standard
• Review / approval of software validation plans, requirements, protocols/ test scripts and final reports
• Management of software validation change control process.
• Serve as validation SME providing guidance and direction to lead validation activities for software projects
• Represent validation team at both internal and external audits and at Quality System Management Reviews when applicable
• Responsible for the overall administration of the document control program related to software validation
ESSENTIAL FUNCTIONS OF THE ROLE • Strong communication skills both verbal and written
• A high level of attention to detail, to ensure accuracy and full compliance with procedures
• Strong work ethic and an ethos of Right-First-Time
• Total commitment to quality and maintaining a high standard of work at all times
• Strong interpersonal skills
• Strong leadership skills with the ability to influence change when needed
• Good project management skills including organization and planning
• Ability to work independently and remotely with minimum direct supervision WORK EXPERIENCE REQUIREMENTS • Number of Overall Years Necessary: 2-5
• Experience working with computer systems, software validation, or related field is essential
• Computer Systems Validation experience and understanding of applicable regulations (Annex 11, GAMP, 21 CFR Part 11)
• Regulated environment, medical devices experience is preferable
• Previous people management (direct or indirect) experience is preferable
EDUCATION REQUIREMENTS
• Bachelor’s Degree in a scientific or engineering discipline required
• Advanced Degree desired SPECIALIZED SKILLS / TECHNICAL KNOWLEDGE • Good knowledge and understanding of the medical device quality and regulatory requirements, including ISO13485, GAMP 5, IEC62304, 21CFRpart 820, part 11 as well as other Computer System Validation processes
• Demonstrated working knowledge in the principles and effective implementation of software validation methodology
• Experience in the review, evaluation and testing of systems to ensure compliance with FDA Electronic Records/Electronic Signatures regulations
• Good overall knowledge with IT infrastructure and applications
• Experience of testing GAMP Category 3, 4 & 5 systems
• Strong oral, written communication, and interpersonal skills
• Ability to work closely with people at all levels of the organization and with persons from different cultural, language and regional backgrounds to accomplish assigned project goals
• Must be results driven striving to meet all targets and prioritize/manage project deliverables
• Experience interacting with auditors preferred
Pay Rate Range: $40-55/hr. Salary will be commensurate with experience
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