Position: Several positions available

Job Type: Contract

Duration: 1 year

Work Location: Puerto Rico and USA

Job description: The Computer Systems Validation (CSV) Specialist is responsible for generating, reviewing, executing, and reporting technical protocols for Syncade MES platform.

• Minimum of 5 years of experience working in qualification activities for Emerson’s Syncade MES Platform.
• Generation of CVS Project Plan.
• Generation of User Requirement Specification (URS) document for MES.
• Functional / Requirement Specifications (FS/DS) documents for Syncade MES Platform.
• Generate Computer and Computerized System Impact Assessment.
• Electronic Records and Electronic Signatures (ERES) Documentation generation.
• Generation of Installation and Qualification Protocols (IQ/OQ) to support the Computer and Computerized System Validation Activities.
• Create and execute EBR recipe validation tests.
• Develop and perform revisions to GMP documents such as procedures, work instructions, forms, and training material.
• Provide EBR Training and Go-Live support.
• Provide support for Change Control development.

Requirements:

• Bachelor’s degree in mechanical, chemical, electrical engineering or Bachelor of Science in a related field with 5 years of experience in manufacturing processes, automation and quality.
• 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 in MS Project, Excel, World etc.
• Fully fluent in English.

Compensation:

Competitive market compensation will be based on experience.

To apply, please send resume to vicky.paz@principiapr.com