Equipment & Projects Specialist
The Equipment and Projects Specialist will be responsible for supporting the qualification of pharmaceutical equipment, utilities, and systems used in sterile injectable manufacturing.
Main Responsibilities:
* Develop, execute, and review Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for sterile manufacturing equipment.
* Maintain the validated state of manufacturing equipment, clean utilities, and process support systems.
* Qualify and validate aseptic filling lines, lyophilizers, autoclaves, depyrogenation tunnels, and isolator/RABS systems.
Requirements:
* Bachelor or Master degree in Engineering (Mechanical, Chemical, Biomedical, or related field) or Life Sciences.
* Over 5 years of experience in validation, equipment qualification, or technical services within sterile injectables manufacturing.
* Familiarity with endotoxin spiking procedure could help with micro resource shortage in relation to depyrogenation tunnel qualification. Lean Six Sigma or ASQ Certified Quality Engineer (CQE) certification is advantageous.
Benefits:
* A challenging and dynamic work environment.
* Opportunities for professional growth and development.
Additional Information:
This role requires a strong understanding of regulatory requirements and industry standards. The successful candidate will have excellent problem-solving skills and be able to work effectively in a team environment.