Description
IMPORTANT: Suppliers should not submit workers whose physical residence is within the following states due to Intuitive tax and operating entity structure:
Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, and Tennessee.
Please interpret this as Intuitive policy to which all suppliers are required to comply.
- Important Notes to supplier: *** (US)
- Sub-vending not allowed - Worker need to be on your direct W2.
- Need to do a proper-pre technical screening.
- Need to have recruiter screening summary on top of resume.
- Including Skill matrix and Writeup from worker on these skills is a plus.
- All past projects should have Durations and locations.
- Current location must be mentioned on the resume.
Actual Title of the role: Validation Engineer 3
Duration: 6 months
Contract/possibility for conversions: NA
Max BR: BR0/hr.
Onsite/Hybrid/Remote: Remote
Only Locals/Nonlocals can be submitted: Both
Mode of interview: Zoom
No of rounds of interview: 2
Top Skills
Bachelor s degree (B.S.) in related field or equivalent.
Five year s related experience or equivalent in a Medical Device or FDA Regulated industry.
Knowledge of fundamental cGMP concepts and FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, ISO 13485:2003 and ISO 9001 Standards
Strong knowledge of FDA Regulated manufacturing processes, process validation, computer and equipment validation, and GMPs.
Ability to develop clear, concise, and timely oral and written reports. Excellent written and oral communication skills
Ability to work on complex projects with general direction and minimal guidance.
Ability to handle multiple projects and meet deadlines.
Ability to manage priorities and workflow. Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
Detailed Job Description
This position has responsibility and authority for:
Development and approval of Validation Plans, IQ, OQ Protocols, Trace Matrices, Risk Assessments and Validation Summary Reports
Analysis of current business processes to translate development documents into user requirements and functional design specifications
Establish validation standards, develop testing protocols, prepare equipment, document test results and maintain records for later analysis
Documentation And Remediation Of Deviations Resulting From Validations/qualifications.
Utilizes established protocols to perform validation and qualification tests and provide detailed and accurate analysis of test results, identifying validation failures and areas of non-conformance
Provide assistance and guidance in training co-workers on validation protocols and operating procedures.
Oversees external validation resources that may be used in the validation project
Author assigned Operating Procedures (SOPs & DOPs) and Policies to ensure compliance with Company policies and federal regulations.
Support regulatory agency inspections/audits, as required.
Must be familiar with cGMPs and current industry guidelines.
Interfaces between various internal and external functional areas to assure successful integration and completion of validation activities in overall project schedules.
Applies quality standards, policies, procedures, and knowledge of current industry/regulatory standards for validation implementation, execution and completion
Maintains awareness of regulatory requirements Job Posting Type
Additional Details
- Pre-identified worker (First Name, Last Name) & Supplier Name : (No Value)
- Job Posting Type : Agency Recruited Worker Required
- Worker Legal Name (For Manager Sourced Only) : (No Value)