PACIV
Overview
Join to apply for the
CSV Specialist/Engineer IT Systems
role at
PACIV
in Puerto Rico. 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. Responsibilities / Essential Functions
Develop and execute CSV deliverables throughout the System Development Life Cycle (SDLC), including Validation Plan, User/Functional Requirements, Design Specifications, Testing, Traceability Matrix, Data Integrity Assessments and Final Reports for Industrial and IT systems. Understand and apply CSV regulations and guidelines such as FDA guidelines, cGMP for the 21st Century, 21 CFR Part 11 Guidance: Scope and Application, 21 CFR 211.68, Data Integrity and Compliance with CGMP, 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 Skills
Significant understanding and experience with the FDA’s regulations regarding CSV, including data integrity, electronic batch records, and related industry standards for the 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 Ability to work under uncertainty and pressure Collaborative team player with accountability Results-driven and self-motivated Strong interpersonal and communication skills (verbal and presentation) Organized with strong computer literacy (MS Project, PowerPoint, Word, Excel, etc.) Excellent communication skills (oral, written, and reading) in Spanish and English Benefits
Full-time job Competitive Salary Health Insurance Vision Insurance Life Insurance Complementary plans 401K Vacation and Sick days Trainings Seniority level
Entry level Employment type
Full-time Job function
Information Technology Industries: Wireless Services, Telecommunications, and Communications Equipment Manufacturing
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Join to apply for the
CSV Specialist/Engineer IT Systems
role at
PACIV
in Puerto Rico. 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. Responsibilities / Essential Functions
Develop and execute CSV deliverables throughout the System Development Life Cycle (SDLC), including Validation Plan, User/Functional Requirements, Design Specifications, Testing, Traceability Matrix, Data Integrity Assessments and Final Reports for Industrial and IT systems. Understand and apply CSV regulations and guidelines such as FDA guidelines, cGMP for the 21st Century, 21 CFR Part 11 Guidance: Scope and Application, 21 CFR 211.68, Data Integrity and Compliance with CGMP, 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 Skills
Significant understanding and experience with the FDA’s regulations regarding CSV, including data integrity, electronic batch records, and related industry standards for the 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 Ability to work under uncertainty and pressure Collaborative team player with accountability Results-driven and self-motivated Strong interpersonal and communication skills (verbal and presentation) Organized with strong computer literacy (MS Project, PowerPoint, Word, Excel, etc.) Excellent communication skills (oral, written, and reading) in Spanish and English Benefits
Full-time job Competitive Salary Health Insurance Vision Insurance Life Insurance Complementary plans 401K Vacation and Sick days Trainings Seniority level
Entry level Employment type
Full-time Job function
Information Technology Industries: Wireless Services, Telecommunications, and Communications Equipment Manufacturing
#J-18808-Ljbffr