Wilmington, United States
about 2 months ago
- Preparing validation and performance qualification protocols for manufacturing processes, systems, electronics, or other types of production.
- Processing automated lab test stations or other test fixtures and equipment.
- Communicating with agencies regarding compliance documentation validation results.
- Maintaining validation test equipment
- Determine process capability of equipment through execution if protocols; incorporating into respective operating procedures and batch records.
- Identifying deviations from established equipment, product or process standards and provide recommendations for resolving deviations.
- Participating in internal/external training programs to maintain knowledge of validation principles, industry trends, or novel technologies.
- Preparing, maintaining, or reviewing validation and compliance documentation, such as engineering change notices schematics, or protocols.
- Studying product characteristics or customer requirements and confer with management to determine validation objectives and standards.
Desired Skills / Experience
- Bachelor's degree in a technical field i.e., Biology, Chemistry, Engineering and minimum
- 8-10 years related experience and/or training; or equivalent combination of education and experience.
- Experience in interpreting graphs, charts, engineering diagrams (P&\O), blueprints, specifications, equipment manuals and guides and other instructions to solve problems.
- Experience writing test plans, procedures and project schedules.
- Experience writing User Requirements, Functional Requirements, Design Specifications, FAT's, SAT's, IQ's, OQ's, PQ's.
- Experience executing FAT's, SAT's, receipt verification, IQ, OQ, PQ.
- Experience using scientific rules and methods to solve problems,