CSV Specialist

Ultimate Solutions•East, PR

4d•Onsite

About The Position

Provides Engineering support in the development of the CSV strategy, implementation, testing, commissioning, and execution of validation activities in accordance with the project scope. The successful candidate must have experience in the regulated environment industries.

Requirements

Minimum 4 years in automation, validation or related engineering experience.
Experience with fully or semi-automated mechanical assembly manufacturing.
Project Management skills
Experience with CSV and validation documentation.
Fully Bilingual (English/Spanish)
Applicants must be currently authorized to work for any employer in the United States on a full-time unrestricted basis.
Employment visa sponsorship is not available.
Not open for Corp-to-Corp arrangements.

Responsibilities

Leadership for the CSV workstream for the AML1 Line 4137 Packaging SCADA Upgrade OT Kneat testing development and management.
Kneat protocol development and workflows.
Kneat protocol executions (DT, ACO, FT, etc.)
Manage data Integrity assessment activities including develop/update SCADA Data Integrity Assessment Report (DIA).
Provide onsite support as needed.
Team participation in recurring project status meetings.
Provide monthly forecast/invoice.
Establish required meetings for data gathering and decision making with the SME’s and project resources.
Works closely with the users and technical teams to ensure that the business requirements are clear and well defined, and that the technical solutions meet the business requirements.
Generate any C&Q required document (Ex: qualification plan and qualification summary report).
Ensure the deliverable of all validation documentations associated to the project as requested by Project Plan and Project schedule.
Provide document (SPECs, SOPs, etc.) control support: Documentation upload and workflow management in CDOCS, Generate and maintain a documentation status tracker.