- Prepares and executes validation protocols with minimal supervision
- Prepares validation report packages with minimal supervision
- Performs other duties as assigned.
Required Skills & Abilities:
- Knowledge of cGMPs
- Knowledge of facility systems associated with the manufacture of biopharmaceutical products
- Knowledge of utility systems associated with the manufacturing of biopharmaceutical products
- Knowledge of equipment associated with the manufacturing of biopharmaceutical products
- Knowledge of steam sterilization processes a plus
- Knowledge of computerized systems validation a plus
- Excellent written and oral communication skills
- Working knowledge of Microsoft Office products (Outlook, Word, Excel, PowerPoint).
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 sitting, 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
- Bachelor’s degree in an Engineering field and 5+ years of validation experience
We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law.
If an accommodation to the application process is needed, please e-mail FDBTHR@fujifilm.com or call 979-431-3528.