PACIV, a global leader in industrial automation solutions servicing the Life Sciences sector, is looking for Two (2) Computerized System Validation (CSV) Specialist/Engineer, for its Puerto Rico office.

Job Description:

The Computerized System Validation (CSV) Specialist/Engineer will be responsible for development and execution of the Computerized System Validation (CSV) deliverables within the BioPharma production facilities. In particular, the resource will participate in the execution of gap assessment and remediation activities for the Data Integrity initiative within the client site.

The resource will also be responsible for development and execution of CSV deliverables, as per the System Development Life Cycle (SDLC), such as Validation Planning, URS, SDS, Testing, Traceability Matrix and Final Reporting within Biopharmaceutical manufacturing site processes and systems.

Position Responsibilities/Essential Functions:

Development and execution of gap assessments and remediation activities for the Data Integrity initiatives, within an existing Biotech production facility, for all production and packaging industrial systems.

Strong knowledge of the development and execution of CSV deliverables throughout the System Development Life Cycle (SDLC) such as Validation Planning, User/Functional Requirements, Design Specifications, Testing, Traceability Matrix and Final Reporting for industrial systems.

Understanding and experience with CSV regulations and guidelines such as FDA; cGMP for the 21st Century, 21 CFR Part 11 Guidance: Scope and Application, 21 CFR 211.68, Data Integrity and Compliance with CGMP Guidance for Industry; and ISPE GAMP5.

Requirements:

• Education: Bachelor's degree in Engineering or related science studies (Computer Systems or Engineering preferred).
• Minimum of two (2) years of hands-on experience in computerized system validation (CSV) and data integrity (DI) within the regulated industries.

Desired Hard Skill Sets:

• Significant understanding and experience with the FDA’s regulations regarding CSV, including data integrity, electronic batch records, and all related industry standards for CSV life cycle.
• Knowledge and experience in the development and execution of CSV deliverables throughout the System Development Life Cycle of industrial systems.
• Familiar with gap assessment methodology, planning and execution activities.
• Knowledge of CSV system life cycle concepts and FDA regulatory requirements, including FDA; cGMPs for the 21st Century, 21 CFR Part 11 Guidance: Scope and Application, 21 CFR 211.68, Data Integrity and Compliance With CGMP Guidance for Industry; and ISPEs GAMP5.

Desired Soft Skills:

• Strong analytical and problem-solving skills.
• Deals well with uncertainty and pressure.
• Works well with others, within a team and takes accountability.
• Results driven and self-motivated.
• Strong interpersonal and communication skills (verbal and presentation).
• Organized, with strong computer literacy such as MS Project, Excel, etc.
• Excellent communication skills (oral, written and reading) in Spanish and English.