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CSV Engineer/Specialist
Ultimate Solutions Corp. is a trusted provider of packaging industrial automation, serialization and compliance for the Life Science Industries in Puerto Rico, United States and Europe. Over 2 decades, the Ultimate team has delivered proven results in hundreds of projects and thousands of service hours to the global leaders of pharmaceutical, biotechnology, medical devices and logistics markets.
Description:
Provides support in the completion of commissioning, and qualification activities for the Process Control system in accordance with the project scope. The successful candidate must have experience in the regulated environment industries.
Responsibilities:
Requirements:
Education:
• B.S. in Engineering or Science
Ultimate Solutions Corp is an equal opportunity employer.
Description:
Provides support in the completion of commissioning, and qualification activities for the Process Control system in accordance with the project scope. The successful candidate must have experience in the regulated environment industries.
Responsibilities:
1. Generate, revise and/or execute commissioning and qualification documentation using CDOCs and/or Kneat electronic platform as required:
a. Commissioning & Qualification Plan
b. Automation Test Plan
c. Traceability Matrix
d. Data Integrity Assessment Report
e. Development Testing protocol
f. Automation checkout protocol
g. Commissioning & Qualification Summary Report
2. Provide electronic validation (Kneat) platform support:
a. Document generation and/or review
b. Document execution and review/approval follow-up to assigned staff
c. Discrepancies generation and review/approval follow-up
3.Perform document control tasks to manage the CDOCs & Kneat workflows for different types of documentation such as: SPECs, PTC’s, APPX,Automation Test Plan, Summary Reports, RTM, etc.
a. Commissioning & Qualification Plan
b. Automation Test Plan
c. Traceability Matrix
d. Data Integrity Assessment Report
e. Development Testing protocol
f. Automation checkout protocol
g. Commissioning & Qualification Summary Report
2. Provide electronic validation (Kneat) platform support:
a. Document generation and/or review
b. Document execution and review/approval follow-up to assigned staff
c. Discrepancies generation and review/approval follow-up
3.Perform document control tasks to manage the CDOCs & Kneat workflows for different types of documentation such as: SPECs, PTC’s, APPX,Automation Test Plan, Summary Reports, RTM, etc.
Requirements:
- Minimum 4 years in automation, validation or related engineering experience.
- Experience with CSV and validation documentation.
- Project Management skills
- 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.
Education:
• B.S. in Engineering or Science
Ultimate Solutions Corp is an equal opportunity employer.