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Urgent! CSV Specialist/Engineer IT Systems Job Opening In San Juan – Now Hiring PACIV
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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Unlock Your CSV Specialist Potential: Insight & Career Growth Guide
Real-time CSV Specialist Jobs Trends in San Juan, United States (Graphical Representation)
Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph below. This graph displays the job market trends for CSV Specialist in San Juan, United States using a bar chart to represent the number of jobs available and a trend line to illustrate the trend over time. Specifically, the graph shows 115022 jobs in United States and 2778 jobs in San Juan. This comprehensive analysis highlights market share and opportunities for professionals in CSV Specialist roles. These dynamic trends provide a better understanding of the job market landscape in these regions.
Great news! PACIV is currently hiring and seeking a CSV Specialist/Engineer IT Systems to join their team. Feel free to download the job details.
Wait no longer! Are you also interested in exploring similar jobs? Search now: CSV Specialist/Engineer IT Systems Jobs San Juan.
An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at PACIV adheres to the cultural norms as outlined by Expertini.
The fundamental ethical values are:The average salary range for a CSV Specialist/Engineer IT Systems Jobs United States varies, but the pay scale is rated "Standard" in San Juan. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.
Key qualifications for CSV Specialist/Engineer IT Systems typically include Other General and a list of qualifications and expertise as mentioned in the job specification. Be sure to check the specific job listing for detailed requirements and qualifications.
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Here are some tips to help you prepare for and ace your job interview:
Before the Interview:To prepare for your CSV Specialist/Engineer IT Systems interview at PACIV, research the company, understand the job requirements, and practice common interview questions.
Highlight your leadership skills, achievements, and strategic thinking abilities. Be prepared to discuss your experience with HR, including your approach to meeting targets as a team player. Additionally, review the PACIV's products or services and be prepared to discuss how you can contribute to their success.
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