The selected candidate will provide support to Equipment and process Validation. Must be able to perform Process & Equipment Validations and Qualifications. Test Methods for manufacturing area. In addition be able to review/perform process & equipment validations (IQ, OQ, PQ).
Duties and Resposibilities:
- Plan, write, coordinate, execute, summarize, review process validation protocols.
- Validation, risk assessments, FAT, SAT, Commissioning, IQ, OQ, PQ,
- Deviations, results and approvals for Equipment and Tooling
- Product Transfer, IQ, OQ, PQ, Deviations, results and obtain approvals for New Sealer
- Provide support and approval for all documentation required for Component
- Qualifications and Test Methods for project components and End Items
- Provide support and approval for all documentation required for project deliverable
- Process & Equipment Validation and qualification
- Set-up of Incoming Inspection equipment, ensure satisfactory operation and inspections
- Generate new SOP'S
- Assist meetings and provide weekly reports when applicable
- Project planning and executing, as well as generate CRs for new document
- Performs other related tasks as may be assigned by supervisor
- Assist in coordination of production steps for new product introduction to manufacturing
Requires minimum of 3-5 years of experience in the pharmaceutical, Medical Device or other FDA regulated industry working with Equipment Validation/Qualification and process validations.
Bachelor Degree in Engineering
Must have knowledge in: Process Validations, Equipment Validations, Equipment Qualifications, Test Method Validations. Manufacturing Procedures generation, Component Qualification, QE, experience with documentation, reviewing and approving IQ, OQ, PQ. Technical Writing Skills and parenteral experience.
Ultimate Solutions Corp is an Equal Opportunity Employer