Quality Assurance Computerized System Validation (CSV) Specialist - FUJIFILM Holdings America Corporation

The QA CSV Specialist will serve as technical subject matter expert for FDBC CSV process, including but not limited to GMP enterprise systems, manufacturing systems and computerized equipment, laboratory systems and computerized equipment and validation software tools. The role will also provide QA oversight for Computerized Systems and GMP IT Applications by supporting the ownership, review, and approval (as applicable) of QA records including SOPs, site deviations, CAPAs and change control records related to CSV equipment and GMP IT Applications. The role will work closely with manufacturing, QC, engineering, facilities to ensure compliance of cGMP systems with all internal Quality requirements.

External US

QA Computerized Systems Validation (CSV) Specialist

The QA CSV Specialist will serve as technical subject matter expert for FDBC CSV process, including but not limited to GMP enterprise systems, manufacturing systems and computerized equipment, laboratory systems and computerized equipment and validation software tools. The role will also provide QA oversight for Computerized Systems and GMP IT Applications by supporting the ownership, review, and approval (as applicable) of QA records including SOPs, site deviations, CAPAs and change control records related to CSV equipment and GMP IT Applications. The role will work closely with manufacturing, QC, engineering, facilities to ensure compliance of cGMP systems with all internal Quality requirements.

The successful candidate has excellent communication (written and verbal) skills, can thrive in a fast-paced environment, is quality-minded, detail oriented, and flexible in work schedule availability to meet the demands of a multi-product clinical and commercial phase cellular therapy company.

Reports to: Associate Director, QA Validation

Location: Thousand Oaks, California

Travel: Up to 10%

Primary Responsibilities:

• Participate in development and implementation of validation strategies, policies, and other documentation for CSV systems and IT applications.
• Oversight of Computerized System Validation Maintenance (Requalification) program execution per established procedures.
• Review and approval of validation plans, protocols, and summary reports for CSV systems and IT applications.
• Review and approval of periodic reviews for Computerized Systems and GMP IT applications to ensure validated state in maintained.
• Review and approval of Data Integrity Assurance program deliverables (User Access Review, Audit Trail Review, Backup Review)
• Review, assess and QA ownership for proposed validated system changes via CAPA, Change Control and Work Orders to identify requirements necessary to maintain validated status.
• Work with QA and stakeholder departments to investigate system issues and perform root cause analysis and implement solutions.
• Interface with other departments (e.g., IT, Engineering, Facilities, Manufacturing, Regulatory Affairs, Quality Control and Quality Assurance) to ensure achievement of FDBC’s objectives relating to computerized system validation and associated activities, including compliance with all applicable standards.

Experience Requirements

• Master of Science (M.Sc.) with 2+ years of applicable industry experience; or
• Bachelor of Science (B.Sc.) with 4+ years of applicable industry experience; or
• Associate Degree with 6+ years of applicable industry experience; or
• High school diploma with 9+ of applicable industry experience
• Computerized systems validation experience in the pharmaceutical industry supporting cGMP systems.
• Experience validating manufacturing and QC instruments and equipment, and IT applications.
• Knowledge of relevant regulations and regulatory guidance required to act as a resource for colleagues.
• Independent decision-making capability and ability to think conceptually and understand impact of decisions critical.
• Strong conflict resolution and negotiation skills.
• Excellent verbal and written communication skills; good interpersonal skills.
• Must be able to work in controlled manufacturing environments requiring special gowning.

Salary and Benefits:

• $100k to $130k per year, depending on experience
• Medical, Dental and Vision
• Life Insurance
• 401k
• Paid Time Off

Join us! FDB is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community and the world at large.

FDBC is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, religious creed, sex (includes pregnancy, childbirth, breastfeeding, and related medical conditions), and sexual orientation and any other status protected by state or federal law.

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 place. 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.