Position Title: Instrument Calibration/Validation Engineer I
Business Unit: Sterile Compounding & Repackaging
Reports To: Director of Validation
Organization Relationship/Scope: No Direct Supervisory Responsibilities
Working Conditions: Physical Effort Required
Fagron has an exciting opportunity for an Entry Level Instrument Calibration/Validation Engineer I to work under the direction of the Validation Director in an FDA-regulated environment. This position supports but not limited to, Calibration and Validation of Pharmaceutical Manufacturing Equipment Control Systems, Aseptic Process Simulations (Media Fills) and Stability Studies.
The successful candidate will demonstrate the ability to learn activities and task in a fast-pace pharmaceutical manufacturing environment, make decisions, and capable of setting and balancing priorities. Working under the direction of the Director of Validation and cross-functional partners at all levels of the organization. Willingness to learn and perform “hands on” work, calibration, and validation activities throughout North American facilities.
Perform and document instrument calibration and validation activities on a variety of pharmaceutical manufacturing equipment and troubleshooting and repair, process validation i.e., media fills and stability studies.
- Write and execute validation protocols for equipment and processes Media Fills and Stability Studies.
- Perform certification/calibration of equipment and instrumentation, (temperature, pressure, humidity, RPM, scales, and balances etc.) in compliance with NIST requirements.
- Perform cleanroom and HEPA filtration program testing.
- Operate the Kaye AVS Validator.
- Maintain Instrument calibration databases and ensure compliance with NIST.
- Effectively communicate within own department, as well as other departments, including Engineering, Operations and Quality.
- Knowledge of cGMP requirements for validation in a pharmaceutical environment.
- Work independently with direction from Sr Validation Engineer or Director of Validation
- Ability to manage and adapt to changing priorities and deadlines.
- Work within FDA and cGMP guidelines as related to sterile injectable manufacturing processes.
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.
- Degree in Engineering or scientific discipline or combination of Associate degree and 1-3 years’ 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)
- 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., FDA Industry for Guidance, PDA, ISPE, USP, NIST etc.
- Ability to handle multiple and changing priorities and tight deadlines while remaining detail oriented.
- Good verbal and written communication skills.
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.