What are the responsibilities and job description for the Equipment Validation Specialist (levels III & IV) position at Ageatia Global Solutions?
Jd
Equipment Validation Specialist IV
Contract
6months
Portsmouth, NH 03801
Description
Equipment Validation Specialist (levels III & IV) role ensures all critical GMP equipment and systems are validated and maintained in compliance with user requirements, process parameters and global regulatory guidelines. The role provide Operations, Quality Assurance and regulatory bodies with scientifically sound, documented evidence that systems and processes will perform as required so they can be assured of a quality, compliant manufacturing environment
Equipment Validation Specialist IV
Contract
6months
Portsmouth, NH 03801
Description
Equipment Validation Specialist (levels III & IV) role ensures all critical GMP equipment and systems are validated and maintained in compliance with user requirements, process parameters and global regulatory guidelines. The role provide Operations, Quality Assurance and regulatory bodies with scientifically sound, documented evidence that systems and processes will perform as required so they can be assured of a quality, compliant manufacturing environment
- Provide Subject Matter Expert support to Quality Control, Manufacturing and other departments for the design, operation and troubleshooting of analytical equipment.
- Drive/own the validation plans and execution of analytical equipment changes and process improvements.
- Execution of Installation Qualifications/Operational Qualifications and drafting Performance Qualifications as required.
- Own all forms of TW records including CC/CAPA/Deviations to support project completion.
- Generating User Requirements Specification Documentation, complete Electronic Records/Electronic Signatures, Data Integrity Risk Assessments and Audit Trail Risk Assessments.
- Review analytical equipment, manuals, and devise validation plans
- Procurement of Analytical Equipment which includes ensuring system meets specifications, quotes, budgets and installations.
- Analytical Equipment Ownership
- Identify Quality Issues, involve stakeholders, drive to completion/resolution
- Participate on Risk Assessments
- Review/Approve Commissioning Qualification Validation Documents
- Perform other duties as assigned.
- Advanced technical knowledge of Quality control and manufacturing operations.
- Working knowledge and experience with Quality Systems including deviations, change controls, CAPAs, OTNs, deviations; both the system (TrackWise) and the practical applications in operations
- Knowledgeable in process, equipment, cleaning, and computer system validations to the extent of being able to effectively review and approve protocols and reports and support implementation of new equipment.
- Demonstrated ability to manage medium to large sized projects within required timeframes.
- Demonstrate ability for effective Planning, Organizing and Controlling competency
- Demonstrate sound decision making.
- Ability to work inter-departmentally and with customers.
- Demonstrates role model behaviors for GMP and Safety behaviors
- Strong written and verbal communication skills
- Ability to work in MS Project, Word, Excel, PowerPoint
