CSV Lead

Job Description

Job Description

About Company:

JC Automation Corp. (JCA) was founded in 1997 with the mission of filling a gap between technology and regulatory requirements in the life science manufacturing industry. The company offers highly capable resources at an affordable cost to build solutions and execute projects in: Automation, Control Systems Integration, Information Technology, System Integration and Regulatory Compliance.

JCA is a HUBZone Certified Small Business Firm, NMSDC Certified Minority Business Enterprise, and Certified Critical Industry Supplier. It’s mission is to add value by delivering quality services & solutions on time all the time by transforming processes & technology into business advantages.

About the Role:

The Senior CSV Lead is accountable for the execution of the strategies for IT Computerized Systems, Computer System Validation (CSV) and Data Integrity, to assure site adherence to regulatory requirements, Corporate CSV and Data Integrity Directives, and site procedures and methodologies. The position performs computerized systems validation for the site systems in Sterile manufacturing, Packaging and Inspection Area, Utilities, Facilities and QC/QA functional areas manufacturing facility according to all Federal, International, State and Corporate Regulations.

The position is responsible for the design, development and execution of software and computer validation protocols and computer validation plans for computerized systems supporting the site areas, and assures the systems are compliant with all CSV and data integrity requirements before releasing the system for its intended use. This position must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices (cGMP) required by the job function.

Responsibilities:

• Assures IT Compliance commitments (computer system validation, data integrity, quality compliance) are planned, closely monitored and completed as expected, following all applicable regulations.
• Keeps abreast of regulatory developments applicable to IT Systems, within or outside of the company, and evolves the department’s best practices in compliance control.
• Serves as the Site IT Subject Matter Expert for IT Compliance issues, including but not limited to Data Integrity, 21 CFR Part 11 for computerized systems, and computer system validation in support of laboratories, manufacturing, and packaging operations.
• Ensures the development, implementation, execution and sustainability of an efficient Software/Computer System Validation program for Business, Manufacturing and Quality Systems, aligned with regulatory requirements, Corporate Directives, and site policies.
• Ensures Periodic Reviews for computerized systems are completed as per plan and aligned with regulatory requirements, and site and corporate procedures.
• Develops and maintains an effective process to ensure system documentation (requirements, specifications, drawings, data mappings, qualification protocols and equipment manuals of computerized systems) is properly maintained.
• Identifies computerized systems validation needs through in-house assessments.
• Ensures the execution and sustainability of an efficient Data Integrity program for computerized systems supporting Business, Manufacturing, Utilities/Facilities, Packaging and Inspection Areas, aligned with regulatory requirements, Corporate Directives, and site policies.
• Performs data integrity assessment activities for new and existing site computerized systems and assures all risks are mitigated prior to system release.
• Leads the detection and evaluation of Data Integrity systems deficiencies for the implementation of corrective actions, which will assure correct operation and compliance with regulatory agency requirements.
• Ensures execution plans for computerized system validation, SDLC for eBRs and Data Integrity compliance are performed as per regulatory requirements, and site and corporate commitments.
• Provides recommendations to remediate or mitigate data integrity findings in computerized systems, implements and validates modifications, and assures the systems are maintained in compliance with regulatory requirements.
• Develops computerized systems data mappings to assure these are maintained in alignment with site operations and in compliance with regulatory requirements.
• Fosters creative problem solving and provides technical guidance on computerized systems situations, including data integrity.
• Assures timely closure of incidents, investigations, audit observations, CAPAs and/or change controls for quality computerized systems.
• Communicates to management potential Data Integrity systems situations that can affect quality or compliance, to ensure appropriate management action is taken to correct these problems.
• Supports regulatory agency inspections on IT Compliance and Data Integrity requirements.
• Supports the implementation of computer systems and provides guidance to assure compliance with Data Integrity requirements and all regulatory requirements, company policies and procedures.

Key Qualifications:

• Bachelor’s Degree in Science (Computer Systems or Engineering preferred).
• Thorough knowledge of cGMP, FDA and Data Integrity regulations is a must.
• Experience with computerized system validation methodologies, 21 CFR Part 11, and Data Integrity regulations.
• Minimum of four (4) years of computerized system validation and data integrity experience within pharmaceutical manufacturing operations.
• Proven experience supporting laboratory, sterile manufacturing, packaging and inspection operations.
• Proven skills in project management.
• Ability to impact and influence people and areas within the company to deliver superior business results.
• Excellent communication skills (oral, written and reading) in Spanish and English.

• Prior experience as an Automation Lead or CSV/C&Q Technical Lead on a large-scale pharmaceutical or biotech capital project.
• Experience with alarm management strategy and manufacturing execution system (MES) implementation.
• Experience supporting regulatory inspections and audits related to automation and computer system validation.

Soft Skills:

• Adaptability: working effectively under a dynamic project schedule
• Leadership: providing technical direction across multi-disciplinary teams
• Organization and attention to detail
• Communication: clearly conveying CSV strategy expectations and progress to stakeholders and clients