Om jobbet
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.
Responsibilities:
- Prepare and execute validation protocols and final reports for new and existing manufacturing equipment.
- Operate the Kaye AVS data acquisition system when validating equipment.
- Maintain the Instrument Certification database and ensure compliance with NIST.
- Perform certification and calibration of equipment and instrumentation, (temperature, pressure, humidity etc.).
- Manage outside calibration contractors when certifying controlled room spaces (HEPA Filters, Room Air Changes, Velocity and Smoke Studies.
- Performed instrumentation and equipment repairs when necessary.
- Work within FDA and cGMP guidelines as related to sterile injectable manufacturing processes
Din profil
Profile/Experiences:
- AS and/or equivalent experience in pharmaceutical related discipline.
- 2 to 4 years experiences in a pharmaceutical manufacturing environment.
- General knowledge of the sterile injectable manufacturing processes.
- Experience working in cGMP environments and industry best practices.
- Working knowledge of applicable GMP regulations, particularly 21 CFR Parts 210 and 211.
- Experience with aspects of pharmaceutical GMP regulations (e.g. quality systems, root cause analysis).
- Knowledge of cGMPs.
- Knowledge of applicable industry guidance, i.e. PDA, ISPE, USP etc.
- Ability to handle multiple and changing priorities and tight deadlines while remaining detail-oriented.
- Good verbal and written communication skills
- Ability to communicate comfortably with senior managers and directors.
- Dedicated to meeting expectations and requirements of internal 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.
Vi tilbyder
We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.