The Process Engineer will lead and execute a project regarding packaging components changes for international markets, using their experience in process and packaging validation to generate and close the required changes. Must be able to perform Process & Equipment Validations and Qualifications.
Completer bachelor’s Degree in Engineering related field and minimum of 3-5 years of experience in the pharmaceutical, Medical Device or other FDA regulated industry working with Process Validation/Qualification and Packaging Validations.
- 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 and Manufacturing Process Information - MPIs
- 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.
- Must have knowledge in: Validation Master Plan, Process Validations, Equipment Validations, Equipment Qualifications, Manufacturing Procedures generation, Component Qualification, QE, experience with documentation, reviewing and approving IQ, OQ, PQ. Technical Writing Skills.
- ARIBA, e-Market Place
- Compliance Wire
- Technical writing
- Problem Solving
- MS Office – Excel, Visio, Power Point, Microsoft Project, Word
- Project Management experience managing multi-sites project is a plus.
- Excellent verbal and written communication in English.
Ultimate Solutions Corp is an Equal Opportunity Employer