CSV Specialist/Engineer IT Systems

Puerto Rico
Full Time
Mid Level
PACIV, a global leader in industrial automation solutions servicing the Life Sciences sector, is looking for a Computerized System Validation (CSV) Specialist/Engineer IT Systems, for its Puerto Rico office.

Job Description:
The Computerized System Validation (CSV) Specialist/Engineer will be responsible for development and execution of Computerized System Validation (CSV) deliverables for clients within the Life Sciences Industry, mainly Bio-Pharma and/or Medical Devices.

The resource will be responsible for development and execution of CSV deliverables, as per System Development Life Cycle (SDLC), such as Validation Plan, URS, SDS, Testing, Traceability Matrix, Data Integrity Assessments and Final Reports for manufacturing process related equipment and IT systems.

Position Responsibilities/Essential Functions:

Strong knowledge of the development and execution of CSV deliverables throughout the System Development Life Cycle (SDLC) such as Validation Plan, User/Functional Requirements, Design Specifications, Testing, Traceability Matrix, Data Integrity Assessments and Final Reports for Industrial and IT 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, Power Point, Word, Excel, etc.
  • Excellent communication skills (oral, written and reading) in Spanish and English.
Benefits:
 
  • Full-time Job Type
  • Competitive Salary
  • Health Insurance
  • Vision Insurance
  • Life Insurance
  • Complementary plans
  • 401K
  • Vacation and Sick days
  • Trainings
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