Akkodis
CSV Validation Lead - GxP Compliance & Strategy
Akkodis, Oregon, Wisconsin, United States, 53575
Akkodis is seeking a CSV Validation Lead for a Contract with a client in Oregon City, CA. The ideal candidate will lead validation strategy and compliance for GxP computerized systems, ensuring adherence to corporate SOPs and regulatory standards.
Rate Range: $49/hour to $64/hour; The rate may be negotiable based on experience, education, geographic location, and other factors.
CSV Validation Lead job responsibilities include: Develop and execute validation strategies for GxP computerized systems and infrastructure, ensuring compliance with corporate SOPs and regulatory standards. Author and review validation deliverables, including plans, reports, test strategies, and risk assessments. Coordinate validation activities globally, liaising with business, quality, and informatics teams to maintain audit readiness. Participate in system implementation and maintenance planning, ensuring validated state and adherence to governance processes. Perform impact assessments for changes, manage data migration validation, and support periodic system reviews. Provide consultancy and training on validation processes, driving continuous improvement and process optimization.
Required Qualifications: • Bachelor’s or master’s degree in computer science, Information Technology, or related field. • Minimum 7+ years of experience in IT and Software Validation (CSV, GAMP). • Strong expertise in authoring and reviewing validation plans, reports, and risk assessments for GxP systems. • Proven ability to ensure compliance with regulatory standards and corporate SOPs while managing global validation activities.
If you are interested in this role, then please click APPLY NOW. For other opportunities available at Akkodis, or any questions, feel free to contact me at Deep.Kumar@Pay Details: $49.00 to $64.00 per hour Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
Equal Opportunity Employer/Veterans/DisabledMilitary connected talent encouraged to apply
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www-uat.modis.com/en-us/candidate-privacy
The California Fair Chance Act
Los Angeles City Fair Chance Ordinance
Los Angeles County Fair Chance Ordinance for Employers
San Francisco Fair Chance Ordinance
Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Akkodis
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Rate Range: $49/hour to $64/hour; The rate may be negotiable based on experience, education, geographic location, and other factors.
CSV Validation Lead job responsibilities include: Develop and execute validation strategies for GxP computerized systems and infrastructure, ensuring compliance with corporate SOPs and regulatory standards. Author and review validation deliverables, including plans, reports, test strategies, and risk assessments. Coordinate validation activities globally, liaising with business, quality, and informatics teams to maintain audit readiness. Participate in system implementation and maintenance planning, ensuring validated state and adherence to governance processes. Perform impact assessments for changes, manage data migration validation, and support periodic system reviews. Provide consultancy and training on validation processes, driving continuous improvement and process optimization.
Required Qualifications: • Bachelor’s or master’s degree in computer science, Information Technology, or related field. • Minimum 7+ years of experience in IT and Software Validation (CSV, GAMP). • Strong expertise in authoring and reviewing validation plans, reports, and risk assessments for GxP systems. • Proven ability to ensure compliance with regulatory standards and corporate SOPs while managing global validation activities.
If you are interested in this role, then please click APPLY NOW. For other opportunities available at Akkodis, or any questions, feel free to contact me at Deep.Kumar@Pay Details: $49.00 to $64.00 per hour Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
Equal Opportunity Employer/Veterans/DisabledMilitary connected talent encouraged to apply
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www-uat.modis.com/en-us/candidate-privacy
The California Fair Chance Act
Los Angeles City Fair Chance Ordinance
Los Angeles County Fair Chance Ordinance for Employers
San Francisco Fair Chance Ordinance
Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Akkodis
#J-18808-Ljbffr