Quality control engineer

Descripción general

The position is a quality control project engineer position for an operations transfer project. As QC engineer you will form part of a receiving site project team responsible for bringing in and qualifying manufacturing equipment and analytical equipment for a new media formulation and aseptic filling manufacturing facility.

You will have a paramount role in the team and have responsibilities for writing protocols, executing and reporting on performed qualifications and process validations for a brand new and state-of-the-art manufacturing facility in Alajuela, Costa Rica. During the project phase it is expected that you become very familiar with all QC equipment and processes so you can provide technical supervision and troubleshooting assistance to QC technicians during method validations and routine testing.

The project is a manufacturing consolidation of three medical device operation sites producing liquid media for fertilization treatment. The current operations sites are located in Denmark, USA and Canada and are to be consolidated in an existing manufacturing facility in Alajuela, Costa Rica. In total the project is scheduled to run for 34 months and scopes the transfer of approximately 400 cold chain (2-8 ºC) finished good items.

Requisitos para aplicar

1. Engineering degree in chemistry, biomedical engineering, microbiology or similar with a minimum of 3 years of experience with quality control and equipment qualification and method validation (IQ, OQ, PQ).
2. In-depth understanding of equipment, equipment qualification and analytical method validation. Experience with pH, osmolality, ELISA, Viscosity, Density, RP-HPLC and sterility testing is an advantage.
3. Understanding of aseptic manufacturing or pharmaceutical manufacturing is preferred.
4. Creative individual who can communicate and coordinate good ideas through to implementation.
5. Fluent in Spanish. Ability to communicate well in English, both orally and written.
6. Skilled with MS Word, Excel, Power Point, etc.
7. Thorough understanding of medical device manufacturing, especially as it relates to FDA (GMP) manufacturing requirements