PharmEng Technology is currently seeking Validation Consultants for an opportunity in Kentucky. Consultants will be responsible for general validation, with heavy focus on Equipment Validation, and must also have solid working experience with manufacturing design and commissioning.
- Prepares, reviews and executes Utility / Facility qualification protocols, prepares/reviews qualification reports and other relevant documents as they pertain to specific validation requirements.
- Prepares and reviews changes to the SOPs pertaining to Equipment / Utility / Facility qualification.
- Reviews and assesses changes and their impact to the qualification status following appropriate change control procedures.
- Provides technical support in resolving Utility / Facility qualification related exceptions, deviations.
- Reviews documents validation related documents as for compliance to the Utility / Facility qualification requirements and good documentation practices.
- Minimum 3 years’ experience working in a similar or related role in the Biotech, Pharmaceutical or Medical Devices industry.
- Must hold a Science or Engineering degree in relevant field or at least 5 years’ experience working in a Validation role.
- Highly capable of developing, executing and reviewing validation protocols (IQ/OQ/PQ/URS/etc.).
- Knowledge of validation principles, standard concepts, practices, procedures and requirements in GMP regulated environments.
- Excellent verbal and written communication skills.