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Validation Engineer 3

EXTRA HOLIDAYS

Remote:

Full Remote

Contract:

Fixed term

Experience:

Mid-level (2-5 years)

Work from:

Canada, California (USA), United States

Offer summary

Qualifications:

Bachelor's degree in a related field, Five years of experience in Medical Device or FDA regulated industry, Knowledge of cGMP concepts and FDA regulations, Strong knowledge of validation processes and GMPs, Excellent oral and written communication skills.

Key responsabilities:

Develop and approve Validation Plans and Protocols
Analyze business processes into user requirements
Establish validation standards and develop testing protocols
Document deviations and manage validation outcomes
Support regulatory inspections and guide training

TalentBurst, an Inc 5000 company Human Resources, Staffing & Recruiting Large https://www.talentburst.com/

1001 - 5000 Employees

See more TalentBurst, an Inc 5000 company offers

Job description

Your missions

Actual Title of the role: Validation Engineer 3
Duration: 6 months
Contract/possibility for conversions: NA
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.

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