Validation Scientist Job Listing at Kelly Services in Bristol, TN (Job ID US3633954_BH10048964)

Description

Senior Validation Specialist – Direct Hire (Permanent)

Location: Bristol, TN
Reports to: Technical Operations / Quality Leadership
Schedule: Full-time, on-site
Salary: $80,000–$95,000/year

Your Impact

• Play a lead role in the implementation and validation of a new LabVantage LIMS, scheduled for go-live in late February/early March.
• Oversee computer system validation (CSV) for LIMS, Waters Empower (HPLC), SAP interfaces, and other QC computerized systems.
• Create and execute validation protocols for processes, equipment (IQ/OQ/PQ), cleaning procedures, facilities, and computerized systems.
• Ensure systems are configured, qualified, and functioning as intended while maintaining compliance with FDA, cGMP, and data integrity requirements.
• Serve as the technical SME for QC laboratories, supporting analytical method development, troubleshooting, and equipment validation.
• Analyze laboratory and process data, conduct statistical evaluations, and prepare technical reports, risk assessments, and regulatory documentation.
• Support process validation activities for oral solid dosage forms, ongoing commercial manufacturing, and R&D initiatives.
• Collaborate cross-functionally with QC, IT, Technical Support, and service providers to resolve issues, optimize workflows, and provide training.
• Maintain and update system specifications, test methods, product configurations, and master data within LIMS and SAP.
• Support CMC supplements, Annual Product Reviews, regulatory filings, and documentation for product registrations.
• Identify and implement process improvements that enhance compliance, efficiency, and operational performance.
• Ensure laboratory systems operate reliably; promptly escalate any hardware/software or operational issues.
• Promote a culture of safety, compliance, and scientific excellence throughout technical operations.

What You'll Bring Core Experience:

• Strong technical background in validation within a pharmaceutical, GMP-regulated environment.

• Hands-on experience supporting computerized systems, including configuration, testing, troubleshooting, and lifecycle documentation.

• Experience with process validation, equipment qualification, and analytical/QC laboratory support.

• Demonstrated skill in preparing technical documentation such as validation protocols, risk assessments, SOPs, and investigation reports.

• Ability to analyze laboratory and process data, including statistical evaluation for APRs and process monitoring.

• Clear communication abilities with experience training teams and collaborating across functional groups.

• Proven ability to independently solve problems, manage multiple priorities, and drive compliance-based improvements.

Technical Qualifications (Required):

• Bachelor's degree in a scientific, engineering, or related field.
• Strong experience in computer system validation and/or process/equipment validation.
• Proficiency with LIMS (LabVantage preferred), Chromatography Data Systems (Empower), and SAP or similar ERP systems.
• Familiarity with analytical laboratory operations, instrumentation, and data integrity requirements.
• Knowledge of validation lifecycle principles, cGMP, FDA expectations, and regulatory compliance practices.
• Capability to perform statistical analysis and interpret QC/process data for decision-making.

Technical Qualifications (Preferred):

• Advanced degree (MS or PhD)
• 7+ years of validation experience within pharmaceuticals, biotechnology, or related regulated industries.
• Experience supporting oral solid dosage forms and commercial manufacturing processes.
• Expertise in configuring and optimizing QC laboratory systems (LIMS, CDS, etc.).

Behaviors & Competencies

• Communicates clearly and effectively with technical and non-technical audiences.
• Demonstrates strong attention to detail and commitment to data integrity.
• Comfortable working across departments and with external vendors or consultants.
• Proactive in identifying risks, proposing solutions, and implementing corrective actions.
• Highly organized, able to prioritize effectively, and skilled at managing multiple concurrent projects.
• Approaches challenges analytically and encourages continuous improvement.
• Supports a culture of compliance, safety, and high scientific standards.
• Adapts well to changing project priorities—especially in a fast-paced validation environment.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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