Validation Engineer / Sterilization Validation Specialist
We are currently seeking an experienced Validation Engineer with strong CQV (Commissioning, Qualification, and Validation) experience for a leading pharmaceutical project. The ideal candidate will have hands-on experience in cycle development, thermal/temperature mapping, and high-level specification writing, with a particular focus on autoclave and sterilization systems within GMP environments.
Key Responsibilities:
Lead the cycle development and qualification of pharmaceutical sterilization processes, including moist heat and autoclave systems.
Execute temperature and thermal mapping protocols in accordance with industry regulations and internal quality systems.
Collaborate with cross-functional teams (Engineering, QA, Automation) to develop and review URS, FDS, and high-level specifications.
Manage the qualification lifecycle of autoclaves and other sterilization equipment (FAT/SAT, IQ, OQ, PQ).
Perform troubleshooting, deviation investigations, and corrective actions related to sterilization or utility validation processes.
Support GMP documentation processes, including protocol authoring, execution, and final reporting.
Requirements:
Degree in Engineering, Life Sciences, or a related technical field.
Minimum 3-5 years of validation/CQV experience in the pharmaceutical or biotech industry.
Proven experience with cycle development, autoclave qualification, and temperature mapping.
Familiarity with cleanroom environments, containment systems, and GMP compliance.
Strong understanding of commissioning documentation and qualification protocols (IQ/OQ/PQ).
Excellent communication skills and ability to work cross-functionally in a regulated environment.
Preferred Skills (Nice to Have):
Experience with isolators, vial filling lines, or sterile manufacturing environments
Knowledge of GAMP 5, risk-based validation, and data integrity principles
Familiarity with equipment such as biosafety cabinets, laminar airflow units, or fume hoods
Apply Now:
If you are a detail-oriented Validation Engineer with CQV experience and a passion for delivering excellence in GMP environments, we'd love to hear from you.