Summary: The Validation Manager will be responsible for drafting and executing cleaning, process validation, utility, process systems and process support systems qualification test work. Preparing validation summary reports for the qualification and validation of systems used to manufacture drug or biologics products.
- Effectively schedule validation activities in co-operation with other departments, company priorities, and department goals.
- Coordinate resources and personnel to achieve company and department goals
- Pre-approve and post-approve qualification protocols.
- Execute protocols and aseptic process simulations.
- Approves the resolution of discrepancies encountered during protocol execution.
- Approves qualification summary reports.
- Investigate and close-out exception reports and non-conformances associated with validation studies.
- Assist in continuous improvement for the department by evaluating systems to improve functionality and efficiency.
- Performs other duties as needed.
Required Skills & Abilities:
- Demonstrated knowledge and experience in process systems associated with the manufacture of a biopharmaceutical product.
- Demonstrated knowledge and experience of cleaning processes.
- Demonstrated knowledge and experience in clean room qualifications.
- Demonstrated knowledge and experience of manufacturing process validation.
- Demonstrated knowledge of cGMP compliance.
- 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.
- Attendance is mandatory.
Required Minimum Qualifications:
- Bachelor’s Degree preferably in Life Sciences, Chemical or Mechanical Engineering and 6 years of experience in validation activities in facilities commissioning and systems qualification of which 4 years must have been in a supervisory or managerial role.
- Advanced degree
- Biotechnology Certification
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.