This position is responsible for validation activities in a cGMP /CBER regulated medical device manufacturing environment. This position will prepare, review and or approve validation documents for new and existing products, including the manufacturing and filling processes for bulk reagents as well as cleaning procedures for production equipment. Duties include prepare, review and or approve of validation plans, protocols and reports.
Participates on and leads validations and projects within the manufacturing areas including but not limited to:
- validation and implementation of new or transferred manufacturing process and cleaning validations;
- assessing existing manufacturing processes and identifying improvement for implementation with guidance from manager and senior engineers;
- design and execute engineering (pre-validation) studies to support validation activities.
- assisting in troubleshooting of process issues, process characterization and root cause investigations.
- prepare and present technical information and project summaries to peers and management.
- ability to manage priorities based on the needs of the manufacturing area with some guidance from the reporting manager and senior management.
- Bachelor’s degree in Engineering or related field, or equivalent combination of education and work-related experience, required.
- Master’s degree, preferred.
- 3-5 years experience in manufacturing engineering, preferably in a biotech or diagnostic equipment industry, required.
- 5-6 years experience in manufacturing engineering, preferably in a biotech or diagnostic equipment industry, preferred
- Demonstrates potential for technical proficiency, engineering creativity, collaboration with others, and independent thought. Demonstrated troubleshooting and problem solving skills including the use of designed experiments. Strong teamwork skills.
Roche - 2 years ago
Roche is on a medicinal roll. The company operates two segments, pharmaceuticals and diagnostics, and sells its products in some 180...