CSV Manager

College Station, TX - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

The job posting is outdated and position may be filled

Job Summary

Position Overview

The Manager CSV will be responsible for management scheduling and oversight of all GxP-Regulated Computerized Systems at all applicable points of the computerized system lifecycle ensuring compliance with regulatory requirements Computer Systems Validation (CSV) and Lifecycle procedures with Data Integrity requirements at each of our 4 Manufacturing Buildings (NCTM TBF-100 FBF-200 FBF-300). The Validation Manager will be responsible for updating the corresponding manufacturing buildings Systems Master List Requalification Schedule and management of Validation Engineers/Specialists for day-to-day validation activities. They will provide oversight of validation activities lead the development and approval of validation documentation risk assessments work with project teams to determine which elements should be validated and conduct impact assessments of proposed changes to computerized systems.

Company Overview

The work we do at FUJIFILM Biotechnologies Texas has never been more importantand we are looking for passionate mission-driven people like you who want to make a real difference in peoples lives.

From developing the next vaccine to advancing cell and gene therapies we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions.

If youre ready to help transform the future of medicine join FUJIFILM Biotechnologies. We offer a flexible work environment and were proud to cultivate a culture that will fuel your passion energy and drivewhat we call Genki.

Our state-of-the-art biomanufacturing facility is located in in College Station Texas which combines a small-town feel with vibrant culture top-notch schools and close proximity to big city life. Nestled between major hubs its a dynamic location that blends convenience with innovation.

Fujifilm is globally headquartered in Tokyo with over 70000 employees across four key business segments of healthcare electronics business innovation and imaging. We are guided and united by our Group Purpose of giving our world more smiles. Visit: Description

Reports to Associate Director Validation

Work Location College Station TX

Primary Responsibilities:

Effectively schedule validation activities in co-operation with other departments company priorities and department goals.
Supervises the activities of the corresponding manufacturing buildings internal validation staff as well as external validation contractors. Establishes validation priorities to ensure that deadlines are met.
Pre-approve qualification protocols and post-approve summary reports.
Generate obtain approvals and execute validation deliverables for computerized systems and relevant infrastructure including Validation Plans Requirements Specification Risk Assessments Installation/Operational Qualifications Traceability Matrices and Validation Final Reports ensuring documents meet regulatory and procedural requirements of 21 CFR Part-11 Annex-11 Data Integrity and GAMP5 among others.
Plan and organize validation activities amongst cross functional groups; capable of providing and maintaining status updates for validation activities related to day-to-day operations or project work
Must be able to review all System Delivery Life Cycle (SDLC) deliverables provide constructive feedback and ensure that the deliverables adhere to associated Standard Operating Procedures (SOPs).
Must be able to create review and update SOPs forms templates documentation and files.
Performs other duties as needed.

Qualifications:

Masters Degree and 5 years of direct Validation experience in pharmaceutical biotechnology or related industry preferably in FDA-regulated environments OR;
Bachelors Degree and 7 years of direct Validation experience in pharmaceutical biotechnology or related industry preferably in FDA-regulated environments.
Degree in Engineering or Science discipline is preferred.
4 years experience in supervision of personnel.
Assist in managing the activities and overseeing validation full time employees and/or contractors for the corresponding manufacturing building.
Demonstrated knowledge and experience in process systems associated with the manufacture of a biopharmaceutical product.
Knowledge of DeltaV automation platform preferred.
Working knowledge of engineering principles.
Working knowledge and expertise in computerized systems validation.
Computer System Validation experience with DCS SCADA and BMS systems such as DeltaV Factory Talk View Desigo Unicorn Wonderware is preferred.
Thorough knowledge of 21 CFR Part 11 Annex 11 Data Integrity GAMP5 requirements and FDA industry regulations.
Excellent written and oral communication skills.
Working knowledge and experience in Microsoft Office products (Outlook Word Excel Power Point).
Ability to work with minimal supervision.
Desire to work in fast-paced state of the art alternately research and customized manufacturing facility.
Role model for company core values of trust delighting our customers and Gemba.

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: temperature logger equipment fog machine air sampling equipment.
Working on ladders.
Attendance is mandatory.

To all agencies: Please no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email the internet or in any form and/or method will be deemed the sole property of FUJIFILM unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired no fee or payment of any kind will be paid.

EEO Information

Fujifilm is committedto providing equal opportunities in hiring promotion and advancement compensation benefits and training regardless of nationality age gender sexual orientation or gender identity race ethnicity religion political creed ideology national or social origin disability veteran status etc.

ADA Information

If you require reasonable accommodation in completing this application interviewing completing any pre-employment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department ( or ).

Required Experience:

Manager

Position OverviewThe Manager CSV will be responsible for management scheduling and oversight of all GxP-Regulated Computerized Systems at all applicable points of the computerized system lifecycle ensuring compliance with regulatory requirements Computer Systems Validation (CSV) and Lifecycle proced...