Great opportunity to join the well established Pharmaceutical company on a 12 month contract basis as a Validation Engineer
Validation Engineer – Pharmaceutical – Dublin
To be successful in this role you will have a degree or qualification in an engineering, science or quality related discipline with minimum 3 years working in a medical device manufacturing industry. An in-depth knowledge of validation and change control management in a medical device environment is essential.
Main Responsibilities :
- Process validation needs for new manufacturing processes, equipment introductions, and process adjustments are expertly handled
- Follow established standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs), and all other regulatory requirements while undertaking process validation (OQ & PQ, IQ ).
- To characterize processes and support process validation activities, use six sigma statistical analysis and experimental design tools.
- Complete all validation documents by writing, executing, and reviewing them.
- Coordinates and implements validation change control, as well as procedure and report preparation.
- Works in cross-functional project teams with Development, Manufacturing, Engineering, Quality, and other departments.
- Prepares validation testing summaries for regulatory filings as needed, and provides validations to regulatory authorities.
- Degree in Engineering / Science discipline, with 3+ years relevant experience.
- Extensive understanding and application of validation principles, concepts, practices, and standards particularly in relation to Process Validation.
- Proficient technical report writing skills.
- Experience in regulated industry, FDA, ISO, etc.
- Proficient in current Good Manufacturing, Engineering, Practices etc (GxP).