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Quality Assurance Validation Engineer:
The Quality Assurance Validation Engineer to support validation activities of Quality Control and Operations instrumentation within GMP manufacturing. In this role you will be part of a cross functional team that will be involved in the development, execution, and/or approval of qualification and / or validation of facilities, utilities, equipment, process, cleaning, and computerized systems. You will also support validation lifecycle activities and will participate in the generation, review and/or approval of change controls, CAPAs, and deviations.
Responsibilities:
EOE/ADA
Quality Assurance Validation Engineer
Bend, OR 97701 US
Posted: 11/14/2023
2023-11-14
2023-12-29
Employment Type:
Direct Hire
Division: Life Sciences
Job Number: JN -112023-17907
State: Oregon
Job Description
Quality Assurance Validation Engineer:
- Title: Quality Assurance Validation Engineer
- Location: Bend, OR
- Industry: Life Science/Pharmaceutical
- Salary: Based on Experience
- Employment Type: Direct Hire
The Quality Assurance Validation Engineer to support validation activities of Quality Control and Operations instrumentation within GMP manufacturing. In this role you will be part of a cross functional team that will be involved in the development, execution, and/or approval of qualification and / or validation of facilities, utilities, equipment, process, cleaning, and computerized systems. You will also support validation lifecycle activities and will participate in the generation, review and/or approval of change controls, CAPAs, and deviations.
Responsibilities:
- Generates and/or supports the generation of risk assessments, user requirements specifications (URS), validation plans, change requests, SOPs, CAPAs, and other relevant documents
- Supports validation lifecycle activities to ensure that qualified systems remain in their validated state
- Leads data integrity risk assessments efforts for validated computerized systems
- Leads the validation effort of enterprise and analytical systems at Ser n
- Provides assessments and recommendations related to systems integration needed to preserve the integrity of the data lifecycle
- Supports the qualification/validation effort driven by the MSAT group
- Provides support during clients and regulatory audits
- Bachelor s degree in science, engineering, or related field with 3-5 years of experience in the pharmaceutical industry
- At least three years of experience performing qualifications and/or validations
- Comprehension of current regulations and guidelines (e.g., 21 CFR Part 11, EudraLex Volume 4 - Annex 15, GAMP 5, etc.) and how to apply them to support the validation effort
- Technical writing skills to effectively develop procedures, discrepancies, change controls, CAPAs and associated documents needed to support the validation effort
- Hands-on experience with a minimum of two of the following: qualification of facilities, utilities, equipment and/or computerized systems, cleaning or process validation
- Experience performing data integrity risk assessment is preferable
- Ability to manage multiple projects, create and work within internal timeliness, solve problems, deliver on commitments, and utilize interpersonal skills in a cross-functional team
- Understanding of IT systems, services, and infrastructure is preferred
- Strong time-management skills and the ability to organize and coordinate multiple projects at a time
- Proficiency in enterprise systems, Microsoft Office, and other office productivity tools, with aptitude to learn new software and systems
- Physical Requirements
- Prolonged periods sitting at a desk and working on a computer
- Prolonged periods of mobility between offices and campus buildings
EOE/ADA
