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Validation Engineer 3

Remote:

Full Remote

Contract:

Full time

Experience:

Mid-level (2-5 years)

Work from:

New Jersey (USA), United States

Offer summary

Qualifications:

Bachelor's degree in related field, Five years of related experience, Knowledge of cGMP and FDA regulations.

Key responsabilities:

Develop and approve validation documents
Analyze business processes for user requirements
Establish validation standards and conduct tests
Document deviations from validations and qualifications
Interface with internal and external stakeholders

Katalyst HealthCares & Life Sciences Pharmaceuticals SME https://www.katalysthls.com/

51 - 200 Employees

See more Katalyst HealthCares & Life Sciences offers

Job description

Responsibilities:

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.

Requirements:

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.