
Validation Specialist
1 day ago
Job Title:
Certified Validation Specialist - Laboratory Systems
We are seeking a detail-oriented Certified Validation Specialist to support laboratory operations in a regulated GMP environment. The role involves ensuring that computerized systems and laboratory equipment are validated, maintained, and compliant with regulatory standards, while driving continuous improvement initiatives.
Key Responsibilities:
- Perform validation of QC systems such as LIMS, Empower, CDS, and other analytical equipment.
- Author and execute validation deliverables (URS, Risk Assessments, IQ/OQ/PQ, Traceability Matrix, Summary Reports).
- Manage system lifecycle activities, including change controls, periodic reviews, and data integrity assessments.
- Ensure audit and inspection readiness for validation documentation.
- Contribute to error-reduction and continuous improvement activities within laboratory operations.
Requirements:
- 5 years' experience in CSV within the pharmaceutical or biotechnology industry.
- Hands-on experience with laboratory systems validation.
- Strong knowledge of cGMP, GAMP 5, 21 CFR Part 11, and Annex 11 guidelines.
- Experience supporting audits and regulatory inspections.
- Strong documentation and stakeholder collaboration skills.
Laboratory Systems Validation
cGMP
GAMP
Quality Control and Assurance
Pharmaceutical Manufacturing
Audits
Regulatory Compliance
Data Integrity
Continuous Improvement
System Lifecycle Management
Validation Deliverables
QC Systems
LIMS
CDS
Bioanalytical Equipment
Biopharmaceuticals
Computer System Validation
Pharmaceutical Industry Experience
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