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Senior Process Engineer
2 months ago
About Civica:
Civica is a nonprofit organization dedicated to addressing the ongoing shortages of essential generic injectable medications in the United States. With a mission to provide affordable insulin and other critical medications, Civica aims to ensure that all patients have access to the treatments they need.
Position Overview:
The Senior Process Engineer will be instrumental in preparing the Civica Petersburg, VA facility for production and in the design of facilities and equipment for a newly planned expansion focused on biologics. This role requires a strong technical background to ensure adherence to regulatory standards and to support the development and execution of systems and processes necessary for Good Manufacturing Practices (GMP) operations. The ideal candidate will possess excellent communication skills, adept problem-solving abilities, and the capacity to thrive in a dynamic work environment.
Key Responsibilities:
- Engage in hands-on activities within a collaborative team environment
- Provide specialized knowledge on Commissioning, Qualification, and Validation (CQV) processes
- Contribute to the engineering efforts to establish technical controls
- Oversee CQV activities for designated systems
- Deliver engineering outputs promptly and efficiently
- Identify operational deficiencies and spearhead process improvement initiatives
- Utilize interpersonal skills to facilitate interactions across multiple departments
Qualifications:
- Bachelor's degree in Engineering is mandatory
- Demonstrated mechanical aptitude
- Proven ability to troubleshoot technical issues and manage project implementations
- Strong analytical and problem-solving capabilities
- Ability to collaborate effectively with other teams and take responsibility for assigned tasks
- Flexibility to adapt to shifting priorities
Preferred Experience:
- Minimum of 5 years in sterile injectables or biologics
- Familiarity with drug product processing machinery
- Experience in procuring capital equipment and materials
- Knowledge of cleaning and process validation
- Previous involvement in facility expansion initiatives