Our regional presence in the U.S. is focused on GMP-compliant manufacturing of plasmid DNA products up to 500L. The team has extensive experience up to phase III clinical supply and successfully released more than 100 GMP batches for advanced therapy applications. At our San Diego site, we are currently looking for a Computer Validation Specialist.
The position is responsible for the day-to-day activities relating to the computer validation program at the Wacker Biotech US Inc. site in San Diego, California. The validation specialist will be responsible for the development and execution of the computer system validation (CSV) documentation for the computerized systems and automated control systems at the organization. The individual will be required to work with multiple departments on computerized system/automation projects, implementations, software validations and network infrastructure projects. The position will have a vital role in managing and improving the effectiveness of the computer system validation and data integrity programs at the company.
- Develop and maintain computerized system life cycle documentation: user requirement specifications (URS), functional requirement specifications (FRS), system design specifications (SDS), risk assessments, traceability matrices, standard operating procedures, installation qualification protocols, operational qualification protocols and final reports.
- Develop and execute CSV deliverables, per System Life Cycle (SLC) industry expectations, including validation project plans, URS, SDS, qualification testing, traceability matrices, valve matrices and final reports for automated systems including PLCs, SCADA and factory historian programs.
- Coordinates all CSV activities with constant communication and follow ups with impacted departments.
- Review validation area processes and procedures related to computer validation.
- Participate in the execution of gap assessments and remediation activities for the Data Integrity initiatives at the site.
- Implement risk-based approaches for the validation of computerized systems including hardware, networking infrastructure and software.
- Support maintenance and development of Standard Operating Procedures (SOPs) for computerized systems including change management, network standardization, security, backup/restore and disaster recovery.
- Ensure compliance with regulatory expectations and ensure the Quality Management System (QMS) supports inspection preparedness.
- Provide support during internal and external audits including regulatory inspections.
- Participate with system reviews, deviations, change controls, improvement (upgrade) projects and troubleshooting relating to the organization’s computer infrastructure, network, GXP systems and software applications.
- Assist with other operational based projects as needed to support on-going manufacturing requirements and site goals.
- Bachelor’s degree with a minimum of 8 years of experience in a GxP environment and validation of IT applications and/or equivalent combination of education and experience.
- For this role, the candidate must exhibit ownership and accountability, open communication, respectful interactions with others, collaboration, and effective teamwork skills.
- Direct experience working with Computer Systems Validation.
- Must be able to work in a fast-pace environment.
- In-depth understanding of GAMP 5, 21 CFR Part 11, Annex 11, ICH, Data Integrity Guidance and current global regulatory expectations.
- Direct experience with key Quality Management System processes (e.g., change management, deviations, CAPA and risk management).
- Implementation and validation experience with Quality Control (QC) lab instruments and associated software packages including: HPLC, UV Vis Spectrophotometer, TOC, PCR, FTIR, Plate Reader(s) and CE.
- Experience with validation of Allen Bradley PLC manufacturing/production skids, CIP systems and factory historian systems.
- Familiarly with Facility focused systems including computerized maintenance management systems (CMMS) and building management systems (BMS).