- Develop, implement and maintain equipment and systems qualification and validation protocols. Systems include:
- Steam and Dry Heat Sterilizers
- Refrigerators, Freezers, and Cold Rooms
- Compressed Air
- Purified Water and Water For Injection
- Process Chromatography Systems
- Execute, track and manage protocols.
- Troubleshoot and investigate validation related issues.
- Prepare and present report packages for implementation into SOP requirements.
- Perform other duties as assigned.
Required Skills & Abilities:
- Excellent attention to detail.
- Experience with thermal data loggers such as the Kaye Validator as well as pre and post calibration procedures.
- Working knowledge of cGMP and engineering principles.
- Excellent written and verbal communication skills.
- Ability to work in a team environment.
- Ability to multitask and flexibility to adapt to changing priorities.
- Knowledge of utility and process systems associated with the manufacture of a biopharmaceutical product.
- Strong working knowledge of Microsoft Office Suite (Word, Excel, PowerPoint, etc.)
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
- Experience prolonged standing, some bending, stooping and stretching.
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
- Operation of test equipment such as: Kaye validator, fog machine, air sampling equipment
- Working on ladders.
- Attendance is mandatory.
- Bachelor of Science degree in life sciences, chemical or engineering or related field; OR
- Associates degree in a science or engineering related field and 3 years of experience.