Validation Engineer 3 - Katalyst Healthcares & Life Sciences
South Plainfield, NJ 07080
About the Job
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.
- 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.
Source : Katalyst Healthcares & Life Sciences
