Validation Engineer
We are seeking a highly skilled and detail-oriented Validation Engineer with specialized experience in validating laboratory equipment and computerized systems within regulated environments. This role will be responsible for planning, executing, and documenting validation activities, ensuring strict compliance with internal procedures and applicable industry regulations such as 21 CFR Part 11, GAMP, USP, NIST, GCLP, GLP, and GxP.
Key Responsibilities:
- Lead the validation lifecycle for laboratory equipment and computerized systems, including the development of:
- Validation Plans
- Risk Assessments
- Installation, Operational, and Performance Qualification (IOQ) Protocols
- Computerized System Validation (CSV) IOQs
- Traceability Matrices
- Final Validation Reports
- Execute qualification protocols and prepare comprehensive documentation packages, including original format documents, approvals, and supporting diagrams or schematics.
- Ensure all validation activities meet applicable regulatory and compliance standards.
- Coordinate cross-functional validation activities with QC, QA, IT, and engineering teams.
- Maintain strong documentation practices in alignment with data integrity principles.
Required Technical Experience:
Hands-on validation and qualification experience with a wide range of QC analytical laboratory instruments, including but not limited to:
- Benchtop Laboratory Equipment:
- Biotech PowerWave Reader (Gen5)
- QuantStudio PCR EnVision Plate Reader
- Additional Instruments:
- Analytical Balances
- Benchtop Incubators
- Microscopes
- Echo System SBDA Workstation (Bioassay Analysis Software)
- Cary60 UV-Vis + Dissolution System
- Gas Chromatography & Mass Spectrometry (GC-MS)
- LabX Software
- High-Performance Liquid Chromatography (HPLC)
Qualifications & Competencies:
Minimum 5 years of experience validating laboratory equipment and computerized systems in a regulated pharmaceutical environment. In-depth knowledge of compliance regulations and validation best practices. Strong proficiency in documentation, technical writing, and regulatory report generation. Excellent communication and collaborative skills across multidisciplinary teams. Meticulous attention to detail and commitment to precision, accuracy, and quality. Proficiency in Microsoft Office Suite (Word, Excel, Outlook, etc.). Education Bachelor's Degree in Science, Engineering, or a related technical discipline.