Validation Project Manager

Summary:  The Validation Project Manager will be responsible for managing the execution of multiple validation related projects at FDBT facilities.

External US

Essential Functions:

• 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 validation protocols (when required).
• 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 automated filling systems for biopharmaceutical products.
• Demonstrated knowledge and experience with the facility validation during start-up.
• Demonstrated knowledge and experience in clean room qualifications.
• Demonstrated knowledge of cGMP compliance.
• Excellent written and oral communication skills.
• Working knowledge of Microsoft Office products (Project, 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.

Validation Project Manager Minimum Qualifications:

• Bachelor's Degree preferably in Life Sciences or Engineering and 3 years of experience in validation activities including 1 year managing the execution of validation projects.

Essential Functions:

• Prepares and executes validation protocols.
• Prepares validation final report packages.
• Performs other duties as assigned.

Required Skills & Abilities:

• Working knowledge of cGMPs
• Experience writing and executing validation protocols
• Experience writing validation final reports
• 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

Qualifications:

• 2-4 years of validation experience in a regulated environment

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.