•
•
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status. Kedrion Biopharma is a biopharmaceutical company specializing in the development, production and distribution of plasma-derived products. Kedrion has been producing plasma products for over 40 years and has a market presence in about 100 countries. Our employees are committed to the highest standards and therapies for the patients and clinicians in hematology, immunology, neurology, and transfusion medicine. The Computer Systems Validation Specialist is responsible for implementing FDA 21 CFR Part 11 compliance across automation and computer systems within a GMP production facility. Computer System Validation Specialist is responsible for managing, developing, and implementing Computer System Validation program for the site to ensure compliance with local and global regulatory agency requirements, internal company standards and current industry practices. The focus of the Computer Validation Specialist role is to identify or create industry best practices and implement these within the framework of existing GAMP (Good Automated Manufacturing Process) regulations. Main Responsibilities Computer System Validation Specialist ensures that validation of computer systems comply with regulatory guidelines and standards.
- Performs and leads computer system validation projects related to authoring and executing validation documentation for QMS software, process equipment, automated equipment, and systems according to GAMP 5 Validation Life Cycle
- Perform all aspects of Quality Systems Management processes such as System Impact Evaluation, Electronic Records and Electronic Signature Assessment, Risk Assessment, Change Control, Deviation, Corrective and Preventive Actions as well as Validation Maintenance of automation and computerized systems
- Develop CFR Part 11-compliant computer and automation systems Validation Plans, Qualifications Protocols (IQ/OQ/PQ), User Requirements, Traceability Matrices, Reports, and all documents, and deliverables within the scope of the validation plan
- Evaluate computer and automation systems for compliance gaps such as Data Migration and Backup, Date/Time Stamp, Access Control, Change History and Audit Trail
- Conduct Data Integrity Assessments, FDA 21CFR Part11 and EU GMP Annex11 assessments
- Conduct Audit Trails and Periodic Review of Computer and Automation systems
- Ownership of all procedures related to computer systems validation
- Train and mentor junior associates in computer systems validation
- Interacts with all areas and levels of the company in addition to regulatory agencies, vendors, consultants, and other intended parties.
- Exercise judgment within defined procedures and practices to determine appropriate actions, uses rigorous logic and methods to solve difficult problems with effective solutions.
- Implement corrective actions and coordinates activities in conjunction with the appropriate enabling groups, i.e., engineering, quality, maintenance, operations, etc.
- Acts as customer project manager on engineering projects. Partners with engineering to deliver projects that meet scope, schedule, and budget while fulfilling the operational needs of the project.
Technical Skills
- B.S. degree required in Engineering or Science discipline with a minimum of 2 years of experience in pharmaceutical, biotechnology or FDA regulated industry.
- Must have direct experience in validation of computer/automation/software validation (prepare IQ, OQ, PQ protocol, resolve deviations, prepare final summary report) in compliance with FDA 21 CFR Part 11 and EU GMP Annex 11 regulations.
- Experience in data governance, data integrity assessment, system impact evaluation, risk assessment, audit trail review, security, user access review, RTM, etc. is strongly preferred
- In depth knowledge of FDA guidelines and Global cGMP relevant to 21 CFR part 11 compliance requirements and Global Computer System Validation and ISPE GAMP 5 guidelines
Soft Skills
- Knowledge of basic leadership principles. Focus is on leading/overseeing defined processes, which may require deep, detailed knowledge
- Provide solutions to a wide range of difficult/complex problems which require the regular use of ingenuity, innovation, and creativity. May refer to precedents and policies.
- Able to gather, analyze and interpret information and identify cause and effect relationships.
- Able to adapt and respond positively to situations and people to meet changing work unit priorities
- Ability to work in cross-functional teams with focus on deliverables, timelines, and meeting customer expectations and requirements.
- Good written and verbal communication skills
- Ability to mentor and coach team members