**LIMS Validation Specialist - CSV**

LIMS Validation Specialist - CSV Job Description We are seeking an experienced Computer System Validation (CSV) Consultant to support the implementation and qualification of a LabVantage LIMS platform within a GMP-regulated laboratory environment. The successful candidate will play a critical role in authoring, executing, and driving approval of validation deliverables while collaborating closely with Quality Control, Validation, IT, and the global France-based LIMS project team. This is a highly visible position requiring strong technical writing, project coordination, and stakeholder management skills. Responsibilities Lead the development, execution, and completion of CSV deliverables associated with the LabVantage LIMS implementation. Author and execute validation protocols, qualification documents, and summary reports in accordance with approved validation plans. Coordinate protocol execution activities with Quality Control personnel and ensure timely completion of documentation packages. Drive document review, approval, and resolution of comments to maintain project timelines. Collaborate with local SMEs and global project stakeholders to ensure successful implementation and validation activities. Support Data Migration Protocol execution and reporting based on approved Data Migration Plans. Conduct Operational Qualification (OQ) activities for Certificates of Analysis (CoA) and label generation and verification. Qualify printers and laboratory-connected devices. Perform end-to-end qualification activities confirming proper data transfer between LIMS, ERP, and interfaced systems. Conduct Performance Qualification (PQ) activities. Generate Validation Summary Reports (VSRs). Develop Performance Monitoring Protocol and Report. Essential Skills 5 years of Computer System Validation (CSV) experience. 3 years supporting LIMS systems in regulated environments. Experience writing and executing validation protocols, IQ/OQ/PQ documents, and validation reports. Experience with data migration qualification documentation and Validation Summary Reports (VSRs). Experience supporting GMP-regulated laboratory systems. Strong technical writing and documentation skills. Experience working directly with laboratory, Quality Control, Validation, and IT stakeholders. Excellent verbal and written communication skills. Additional Skills & Qualifications Previous LabVantage validation experience is strongly preferred but not required. Experience with LIMS implementation, upgrades, or migration projects. Familiarity with laboratory workflows and Quality Control operations. Knowledge of GAMP 5, FDA 21 CFR Part 11, Data Integrity, and computerized system validation principles. Experience supporting global project teams and cross-functional stakeholders. Work Environment The position offers a hybrid work schedule with onboarding and training onsite as well as key team meetings or executing protocols. Technical writing can be done at home, following a probable 3-day remote and 2-day onsite schedule, which may need to flex with project needs. Core working hours are flexible with a standard from 9:00 AM to 3:00 PM, though early meetings with French counterparts may be required. Job Type & Location This is a Contract position based out of Bridgeton, MO. Pay and Benefits The pay range for this position is $40.00 - $70.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in Bridgeton,MO. Application Deadline This position is anticipated to close on Aug 13, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: 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. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.