Senior Validation Engineer

Your Job
As part of the Software Engineering & Integration (SE&I) team, you will be part of the team that supports SAP and multiple packaged platforms. SE&I is responsible for the development, configuring, supporting, maintaining, and enhancing emerging technologies and focuses on problem solving and providing innovative solutions to ensure optimal performance and customer experience for our products and applications. As a Verification & validation Engineer you will be a critical part of the team, ensuring the delivery of high-quality software that meets both customer expectations and company standards.

We are seeking a Computer System Validation Engineer (CSV) to support the Georgia Pacific CPG division that is subject to over the counter and similar (e.g., cosmetic, pharmaceutical) regulatory requirements. They will be leading a program to comply with IT related regulatory requirements (e.g., computer systems validations). They will be supporting the maintenance processes associated with the different systems for the GP CPG division, which includes change management, identity and access management, management of data integrity, patch and vulnerability management, records retention, and audit management as it relates to systems involved with managing regulated products. This includes providing objective risk assessments of the compliance with regulatory, organizational and commercial requirements governing the organization's information technology systems.

Supports the overall management of IT related validations and qualifications. Supports all phases of IT validations and qualifications including creation, execution, documentation and approval of plans. Works to ensure new or revised IT Systems are Validated and Qualified in accordance with regulatory standards. Leads document /protocol creation, execute test scripts and ensure Business Quality Team alignment, ensure defects are documented and have a path forward, help with training IT and business on the change management process as it relates to regulated materials, etc.

Our Team
As part of the Software Engineering & Integration (SE&I) team, you will be part of the team that supports SAP and multiple packaged platforms. SE&I is responsible for the development, configuring, supporting, maintaining, and enhancing emerging technologies and focuses on problem solving and providing innovative solutions to ensure optimal performance and customer experience for our products and applications. As a Verification & validation Engineer you will be a critical part of the team, ensuring the delivery of high-quality software that meets both customer expectations and company standards.

We are seeking a Computer System Validation Engineer (CSV) to support the Georgia Pacific CPG division that is subject to over the counter and similar (e.g., cosmetic, pharmaceutical) regulatory requirements. They will be leading a program to comply with IT related regulatory requirements (e.g., computer systems validations). They will be supporting the maintenance processes associated with the different systems for the GP CPG division, which includes change management, identity and access management, management of data integrity, patch and vulnerability management, records retention, and audit management as it relates to systems involved with managing regulated products. This includes providing objective risk assessments of the compliance with regulatory, organizational and commercial requirements governing the organization's information technology systems.

Supports the overall management of IT related validations and qualifications. Supports all phases of IT validations and qualifications including creation, execution, documentation and approval of plans. Works to ensure new or revised IT Systems are Validated and Qualified in accordance with regulatory standards. Leads document /protocol creation, execute test scripts and ensure Business Quality Team alignment, ensure defects are documented and have a path forward, help with training IT and business on the change management process as it relates to regulated materials, etc.

*What You Will Do*

• Design and develop/update validation plans that comprise deliverables, user requirements, functional specifications, platform protocols and application protocols for GxP relevant applications specific to Computer System Validation change management processes.
• Support the Change Management practices, in-house development teams, and change owners. Work with teams to determine if changes are GxP relevant.
• Oversee and prepare test cases and scripts for audit trail, electronic signature, system connectivity, and other platform specifications. Assist in developing an inspection plan for master and transactional data migrated to any new system prior to go-live.
• Oversee and execute validation protocols, prepares deviation reports on system errors, and recommends resolutions aligning with Quality Business partners.
• Develop and maintain relationships with System Owners, Technical Representatives, Business Owners and CPG Quality Business Representatives.
• Provide objective evidence of validation. Notify stakeholders if issues arise during validation.
• Conduct necessary IT Computer System Validation compliance control monitoring and testing activities to determine the effectiveness of the controls (ex: periodic review of validations including review of protocols, updating and executing for all impacted systems).
• Identify and resolve any issue of noncompliance, with a related standard or framework. Remediate IT Computer System Validation control deficiencies.
• Be involved in any scheduled internal/external assessments as it relates to the scope of Computer System Validation processes and take action on any findings from the assessments with alignment from legal and CPG Quality Team.
• Manage the business-critical artifacts (documents) and has accountability for being able to produce the artifacts in case of an FDA audit.

*Who You Are (Basic Qualifications)*

• Minimum 6 - 8 years' validation & qualification writing and executing experience
• Working knowledge of FDA regulations, such as 21CFR Part 11
• Proven organization and time management skills
• A bias for documentation and accuracy with excellent attention to detail
• A self-starter with proven ability to work without direct supervision
• Strong analytical skills while being a creating problem solver.
• Written and verbal communication skills with both IT and Business stakeholder

*What Will Put You Ahead*

• 3+ SAP ERP experience in any of the following processes: (Order to Cash, Master Data, Procure to Pay, or EWM)
• Bachelor's degree in computer science, or other Engineering disciplines.
• 5+ years' validation & qualification writing and executing experience preferably in medical devices or pharmaceutical industry.
• Experience with SAP S/4 upgrades.
• 1+ years' experience working with Salesforce.
• 2+ years project management skills that demonstrate the ability to complete assignments in a systematic and timely basis.

Hiring Philosophy
All Koch companies value diversity of thought, perspectives, aptitudes, experiences, and backgrounds. We are Military Ready and Second Chance employers. Learn more about our hiring philosophy
*Who We Are
At Koch, employees are empowered to do what they do best to make life better. Learn how our business philosophy helps employees unleash their potential while creating value for themselves and the company.*
Our Benefits
Our goal is for each employee, and their families, to live fulfilling and healthy lives. We provide essential resources and support to build and maintain physical, financial, and emotional strength - focusing on overall wellbeing so you can focus on what matters most. Our benefits plan includes - medical, dental, vision, flexible spending and health savings accounts, life insurance, ADD, disability, retirement, paid vacation/time off, educational assistance, and may also include infertility assistance, paid parental leave and adoption assistance. Specific eligibility criteria is set by the applicable Summary Plan Description, policy or guideline and benefits may vary by geographic region. If you have questions on what benefits apply to you, please speak to your recruiter. Additionally, everyone has individual work and personal needs. We seek to enable the best work environment that helps you and the business work together to produce superior results.*
Equal Opportunities
Equal Opportunity Employer, including disability and protected veteran status. Except where prohibited by state law, all offers of employment are conditioned upon successfully passing a drug test. This employer uses E-Verify. Please visit the following website for additional information:
*

• For onsite jobs

"Koch is proud to be an equal opportunity workplace"
We are seeking a Computer System Validation Engineer (CSV) to support the Georgia Pacific CPG division that is subject to over the counter and similar (e.g., cosmetic, pharmaceutical) regulatory requirements. They will be leading a program to comply with IT related regulatory requirements (e.g., computer systems validations). They will be supporting the maintenance processes associated with the different systems for the GP CPG division, which includes change management, identity and access management, management of data integrity, patch and vulnerability management, records retention, and audit management as it relates to systems involved with managing regulated products. This includes providing objective risk assessments of the compliance with regulatory, organizational and commercial requirements governing the organization's information technology systems.

Supports the overall management of IT related validations and qualifications. Supports all phases of IT validations and qualifications including creation, execution, documentation and approval of plans. Works to ensure new or revised IT Systems are Validated and Qualified in accordance with regulatory standards. Leads document /protocol creation, execute test scripts and ensure Business Quality Team alignment, ensure defects are documented and have a path forward, help with training IT and business on the change management process as it relates to regulated materials, etc.

Our Team
As part of the Software Engineering & Integration (SE&I) team, you will be part of the team that supports SAP and multiple packaged platforms. SE&I is responsible for the development, configuring, supporting, maintaining, and enhancing emerging technologies and focuses on problem solving and providing innovative solutions to ensure optimal performance and customer experience for our products and applications. As a Verification & validation Engineer you will be a critical part of the team, ensuring the delivery of high-quality software that meets both customer expectations and company standards.

We are seeking a Computer System Validation Engineer (CSV) to support the Georgia Pacific CPG division that is subject to over the counter and similar (e.g., cosmetic, pharmaceutical) regulatory requirements. They will be leading a program to comply with IT related regulatory requirements (e.g., computer systems validations). They will be supporting the maintenance processes associated with the different systems for the GP CPG division, which includes change management, identity and access management, management of data integrity, patch and vulnerability management, records retention, and audit management as it relates to systems involved with managing regulated products. This includes providing objective risk assessments of the compliance with regulatory, organizational and commercial requirements governing the organization's information technology systems.

Supports the overall management of IT related validations and qualifications. Supports all phases of IT validations and qualifications including creation, execution, documentation and approval of plans. Works to ensure new or revised IT Systems are Validated and Qualified in accordance with regulatory standards. Leads document /protocol creation, execute test scripts and ensure Business Quality Team alignment, ensure defects are documented and have a path forward, help with training IT and business on the change management process as it relates to regulated materials, etc.

*Our Benefits
Our goal is for each employee, and their families, to live fulfilling and healthy lives. We provide essential resources and support to build and maintain physical, financial, and emotional strength - focusing on overall wellbeing so you can focus on what matters most. Our benefits plan includes - medical, dental, vision, flexible spending and health savings accounts, life insurance, ADD, disability, retirement, paid vacation/time off, educational assistance, and may also include infertility assistance, paid parental leave and adoption assistance. Specific eligibility criteria is set by the applicable Summary Plan Description, policy or guideline and benefits may vary by geographic region. If you have questions on what benefits apply to you, please speak to your recruiter. Additionally, everyone has individual work and personal needs. We seek to enable the best work environment that helps you and the business work together to produce superior results.*
Equal Opportunities
Equal Opportunity Employer, including disability and protected veteran status. Except where prohibited by state law, all offers of employment are conditioned upon successfully passing a drug test. This employer uses E-Verify. Please visit the following website for additional information:

• For onsite jobs

"Koch is proud to be an equal opportunity workplace"