Automation Validation Engineer
- Contractor
- Full-Time
- Raleigh, NC
- Splintpharma
- Prefferd visa: OPT, CPT, F1, H4, Have H1 Visa, Need H1 Visa, TN Permit Holder, Green Card Holder, US Citizen
- Posted 2 years ago – Accepting applications
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Offerd Salary $ 35 - $ 45
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Required Position 2-4 hires
-
Experience 0-3 Years Required
Job Opening for Automation Validation Engineer, Raleigh, NC (Client undisclosed) Automation Validation Onsite Rate: $35 to $45 Duration: 12mo+ Job Description: Develop and execute Computerized System Validation (CSV) deliverables for control systems for production equipment including but not limited to Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, Trace Matrices, Test Execution, Summary reports. CSV will be specific to process control systems for process equipment and interfaces. Requirements: Education: Bachelor’s degree in Engineering or related science studies. Prefer five (5)+ years related work experience including strong knowledge and hands-on experience of computer system validation (CSV) activities in the regulated industries. Strong technical writing skills Essential skills: 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. Strong knowledge of the development and execution of CSV deliverables throughout the System Development Life Cycle (SDLC) Knowledge, familiarity and exposure to industrial control systems (PCS, Siemens PLC, or related such as DeltaV or DCS), including related configuration/programming. Strong technical writing skills
Job Opening for Automation Validation Engineer, Raleigh, NC (Client undisclosed)
Automation Validation
Onsite
Rate: $35 to $45
Duration: 12mo+
Job Description: Develop and execute Computerized System Validation (CSV) deliverables for control systems for production equipment including but not limited to Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, Trace Matrices, Test Execution, Summary reports. CSV will be specific to process control systems for process equipment and interfaces.
Requirements: Education: Bachelor’s degree in Engineering or related science studies.
Prefer five (5)+ years related work experience including strong knowledge and hands-on experience of computer system validation (CSV) activities in the regulated industries.
Strong technical writing skills
Essential skills:
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.
Strong knowledge of the development and execution of CSV deliverables throughout the System Development Life Cycle (SDLC)
Knowledge, familiarity and exposure to industrial control systems (PCS, Siemens PLC, or related such as DeltaV or DCS), including related configuration/programming.
Strong technical writing skills