Over de functie
The Validation Engineer will perform and document instrument calibration and validation activities on a variety of pharmaceutical manufacturing equipment. This position requires troubleshooting and repair of new and existing equipment.
- Knowledge of: HEPA testing, equipment calibration, Kaye validator operation, media fills.
- Follow approved SOPs and Protocols when calibrating and validating equipment.
- Maintain instrument calibration databases and ensure compliance with NIST.
- Perform certification/calibration of equipment and instrumentation for temperature, pressure, humidity etc.
- Work within FDA and cGMP guidelines as related to sterile injectable manufacturing (21 CFR parts 210 and 211).
Position Core Competencies
- Ability to communicate comfortably with managers and directors.
- Dedicated to meeting expectations and requirements of internal and external customers.
- Able to communicate clearly and succinctly in a variety of communication settings and styles.
- Has the functional and technical knowledge and skills to do the job at a high level of accomplishment.
- Uses rigorous and logic and methods to solve difficult problems with effective solutions.
- Maintains a conscious balance between work and personal life as to not allow one to dominate the other.
Maak het verschil
- High School Diploma and/or equivalent experience in pharmaceutical related discipline.
- 3 to 5 years experiences in a pharmaceutical manufacturing environment.
- General knowledge of the sterile injectable manufacturing processes.
Candidate Profile (preferred, not required)
- Experience with aspects of pharmaceutical GMP regulations (e.g., quality systems, root cause analysis).
- Knowledge of applicable industry guidance, i.e., FDA Industry for Guidance, PDA, ISPE, USP etc.
- Ability to handle multiple and changing priorities and tight deadlines while remaining detail oriented.
- Good verbal and written communication skills
Wat bieden wij?
Fagron offers exciting opportunities for personal and professional growth. We provide an open and truly dynamic environment which supports and encourages you to develop your skills and talents.