Laboratory Validation Specialist (Fort Worth, TX)
About the position Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. Laboratory Validation Specialist The Laboratory Validation Specialist is responsible for validations supporting the Quality Control laboratories. Primarily the role is responsible for the validation, verification, and/or qualification of test methods used in the laboratories, analytical instruments, and computerized systems used in a GMP-regulated pharmaceutical environment. This role ensures that test methods, equipment, and processes are compliant with regulatory requirements, including method validation standards, data integrity standards and computer system validation (CSV), while supporting reliable and accurate laboratory operations. This role also serves as a Quality Control representative for other site validations that requiring Quality Control support. U.S. Sponsorship or H1B transfer is not available for this role What will you be doing?
Responsibilities
- Lead and execute qualification activities for laboratory instruments (e.g., dissolution, spectroscopy systems).
- Develop and execute validation protocols for methods.
- Manage execution of IQ/OQ/PQ protocols for new and existing equipment.
- Represent QC in the development, review, and execution of validation supporting other site projects and processes.
- Ensure compliance with ALCOA+ data integrity principles.
- Review audit trails, electronic records, and system access controls.
- Support and lead data integrity assessments and gap remediation plans.
- Participate in regulatory inspections and audits.
- Author, review, and approve validation protocols, reports, SOPs, and work instructions.
- Support deviations, investigations, CAPAs, and change control related to validation activities.
- Maintain validation lifecycle documentation in accordance with GMP requirements.
- Apply risk-based validation approaches per GAMP 5 guidelines.
- Perform impact and risk assessments for changes to validated systems.
- Ensure continued process verification and system performance monitoring.
- Work closely with R&D, QA, QC, Manufacturing, IT, Metrology, and Engineering teams.
- Interface with vendors for system implementation, validation support, and troubleshooting.
- Provide technical guidance on validation requirements and best practices.
- Train laboratory personnel on validated systems and compliance expectations.
- Identify opportunities for process improvements and efficiency in validation practices.
- Support digitalization and automation initiatives in the lab.
Requirements
- Bachelor’s degree in Chemistry, Biology, Engineering, Computer Science, or related scientific field.
- 2–6+ years in pharmaceutical, biotech, or regulated laboratory environments.
- Experience with laboratory test method validation, equipment qualification and/or CSV.
- Familiarity with LIMS, CDS (e.g., Empower, OpenLab), or other lab systems.
- GMP (Good Manufacturing Practices)
- Test Method Validation
- Computer System Validation (CSV)
- 21 CFR Part 11 / EU Annex 11
- GAMP 5 guidelines
- Data Integrity (ALCOA+)
- Experience with validation lifecycle documentation (URS, IQ/OQ/PQ)
- Understanding of audit trails, electronic signatures, and system security
- Strong analytical and problem-solving skills
- Attention to detail and documentation accuracy
- Effective communication and teamwork across departments
Nice-to-haves
- Experience supporting regulatory inspections is preferred.
- Experience with automation or system integration (LIMS/ERP) is a plus.
- Knowledge of risk management tools (e.g., FMEA) is a plus.
Benefits
- 401k Matching Program
- 401k Plus Program
- Discounted Stock Options
- Tuition Reimbursement
- Flexible Personal/Vacation Time Off
- Paid Holidays
- Flex Holidays
- Paid Community Service Day
- Medical, Dental, Vision
- Health Savings Account (Employer Contribution of $500+ annually)
- Employee Assistance Program
- Parental Leave
- Fertility and Adoption Assistance Program
- Hybrid Work Model (For most professional roles)
- Discounts on fitness clubs, travel and more!
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