Validation Specialist V - OQSIE
Swiftwater, PA
About the Job
Duties:
- Responsible for processes are validated to required standards. Manage all moderate troubleshooting efforts for protocol discrepancies.
- Responsible for developing moderate complex protocols using a risk-based approach that meets current regulatory requirements and industry practices. Presents the validation approach and protocol results to peers, management as required.
- Reviews and interprets data for accuracy for completed validations/re-validations, and prepares report packages by analyzing and summarizing the data to support test and protocol requirements. Provides technical input to validation deviations; provides assessments for change requests on direct impact systems; and identifies qualification requirements to ensure the validated state is maintained.
- Reviews controlled documents relating to processes, cleaning, equipment, and computer systems validations.
- Process validation background/experience validating commercial drug substance/drug product.
- Biopharmaceutical experience with knowledge of cell culture and purification manufacturing processes.
- Experience with planning and generating validation protocols and reports
- Statistical analysis of manufacturing and QC data for PPQ reports.
- Investigate root cause and implement corrective actions for validation discrepancies
- Excellent technical writing and verbal communication skills
Ability to read/interpret process development and characterization documents
Ability to work as part of a high performing team and collaborate effectively with staff at all levels. - Must have well-developed interpersonal skills with the ability to establish highly functional relationships with diverse personalities both within and outside the company.
- Demonstrated ability to manage multiple activities while maintaining a high level of organization.
Must have a strong understanding of validation principles.
Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision.
Proficiency in Microsoft Office including Word, Excel, PowerPoint, Project and Visio. - Ability to make independent sound decisions and manage priorities in alignment with department and site drivers.
- Ability to interpret and relate Validation standards for implementation and review to functional areas.
- Demonstrate flexibility in problem solving, providing risk-based options towards challenges for Management review and decision making.
- Demonstrate solid understanding and application of small-scale versus production-scale process validation.
- Proficiency in Microsoft Office including Word, Excel, PowerPoint, Project and Visio.
Ability to make independent sound decisions and manage priorities in alignment with department and site drivers. - Ability to interpret and relate Validation standards for implementation and review to functional areas.
- Demonstrate flexibility in problem solving, providing risk-based options towards challenges for Management review and decision making.
- Bachelor's Degree. 6 years of pharmaceutical Quality experience, knowledge of Validation Lifecycle Approach (e.g. ASTM E2500, GAMP).
- Masters Degree with 4 years of pharmaceutical quality experience, knowledge of Validation Lifecycle Approach (e.g. ASTM E2500, GAMP).
Source : OQSIE