Over de functie
Fagron has an immediate opportunity for an experienced Validation Engineer to work under the direction of the Validation Director in an FDA-regulated environment. This position supports validation of Pharmaceutical Manufacturing Equipment Control Systems.
The successful candidate will have the ability to work in a fast-pace pharmaceutical manufacturing environment, make decisions and is capable of setting and balancing priorities. Manage multiple projects with frequent changes and manage validation activities with cross-functional partners at all levels of the organization. Willingness to perform “hands on” work and manage consultants and contractors executing metrology and validation activities throughout the facility.
Summary of Position
Perform and document instrument calibration and validation on a variety of pharmaceutical manufacturing equipment. This position requires troubleshooting and repair of new and existing equipment.
1. Prepare and execute validation protocols and final reports.
2. Perform instrument certification and calibration on a variety of pharmaceutical equipment.
3. Ensure safe and efficient operation of electrical and mechanical equipment and instrumentation. This
involves performing inspections, test, repairs, installation, and/or removal of equipment and
4. Ability to diagnose causes of electrical and mechanical failures of operation using appropriate testing
5. Working knowledge of PC and PLC base control systems software and hardware.
6. Complete scheduled instrument calibrations and qualifications in a timely manner.
7. Working knowledge of FDA and cGMP, guidelines as related to instrument calibration and equipment
8. Familiarity with Kaye Data Acquisition and related standard equipment.
Maak het verschil
Position Core Competencies
1. Ability to communicate comfortably with senior managers and directors.
2. Dedicated to meeting expectations and requirements of internal customers.
3. Able to communicate clearly and succinctly in a variety of communication settings and styles.
4. Has the functional and technical knowledge and skills to do the job at a high level of accomplishment.
5. Uses rigorous and logic and methods to solve difficult problems with effective solutions.
6. Maintains a conscious balance between work and personal life as to not allow one to dominate the other.
• AS, BS degree and/or equivalent experience in pharmaceutical related discipline.
• 3 to 5 years experiences in metrology and validation of pharmaceutical manufacturing equipment.
• Experience working with regulatory agencies.
• General knowledge of the injectable pharmaceutical industry, sterile compounding preferred.
• Experience working in cGMP environments meeting FDA, EMA, ICH guidelines, local regulations, and
industry best practices.
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.