Overview
On Site
Depends on Experience
Contract - W2
Contract - 12 Month(s)
Skills
Computer System Validation
csv
validation
Job Details
Job Title: Validation Engineer II
Work Location: Hillsboro, OR
Computer System Validation Contractor
Must haves:
Good knowledge of Food and Drug Administration regulations/guidance (or Annex) Effective communicator with excellent verbal and written communication skills - will need to build & maintain good working relationships.
Core responsibilities: -
- Be responsible for the review of system documentation according to the client CSV SOPs and regulatory guidance.
- Develop plans and reports such as validation plans/reports, test plans/reports (and other deliverables).
- Update existing validation deliverables and procedures in collaboration with the system owners.
- Apply ALCOA+ principles to validation deliverables and quality management system records.
- Support in deviation investigations to identify root causes and define corrective and/or preventative actions.
- Support system maintenance and enhancement activities, ensuring the validated state is kept, and it is audit and inspection ready.
- Collaborate with local and global stakeholders in defining and completing validation and compliance activities.
Role Minimum Requirements
Education
Bachelor of Science or equivalent in computer science, engineering, life sciences, or related field.
Minimum 6+ years experience in IT, OT or Software Technical Writing, Quality Systems, and Validation (CSV/CSA, GAMP), preferably in a regulated industry.
Good understanding of the ISA-95 model. Experience working with Level 2 and Level 3 systems is required. Experience working with Level 1 systems is a plus.
Good knowledge of Food and Drug Administration regulations/guidance (i.e. CFR 21 FDA Part 11, Annex 11, EU GMP Annex 1, GxP practices) and Data Integrity principles.
Good understanding of system and data risk assessment concepts.
Technical skills
Knowledge of or experience with the following technical areas is a plus: System administration, software development, networking, server administration, MES Systems administration and recipe authoring , Industrial Data and manufacturing controls systems.
Familiarity with IT Service Management, Quality and Document Management systems such as Veeva, HP ALM, Valgenesis, and ServiceNow, is a plus.
Keep abreast of key Manufacturing IT trends and be curious - Smart Buildings, Smart Manufacturing, Industrial IoT, Manufacturing Digital Plant Maturity, Cybersecurity, Pharma 4.0, Data Integrity principles, technology, and data standardization, etc.
Education
Bachelor of Science or equivalent in computer science, engineering, life sciences, or related field.
Minimum 6+ years experience in IT, OT or Software Technical Writing, Quality Systems, and Validation (CSV/CSA, GAMP), preferably in a regulated industry.
Good understanding of the ISA-95 model. Experience working with Level 2 and Level 3 systems is required. Experience working with Level 1 systems is a plus.
Good knowledge of Food and Drug Administration regulations/guidance (i.e. CFR 21 FDA Part 11, Annex 11, EU GMP Annex 1, GxP practices) and Data Integrity principles.
Good understanding of system and data risk assessment concepts.
Technical skills
Knowledge of or experience with the following technical areas is a plus: System administration, software development, networking, server administration, MES Systems administration and recipe authoring , Industrial Data and manufacturing controls systems.
Familiarity with IT Service Management, Quality and Document Management systems such as Veeva, HP ALM, Valgenesis, and ServiceNow, is a plus.
Keep abreast of key Manufacturing IT trends and be curious - Smart Buildings, Smart Manufacturing, Industrial IoT, Manufacturing Digital Plant Maturity, Cybersecurity, Pharma 4.0, Data Integrity principles, technology, and data standardization, etc.
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