Job Description:
- Provide technical assistance to manufacturing and quality operations for process troubleshooting.
- Responsible for continuous improvements, support execution and documentation of development and/or validation studies, and lead in planning engineering, investigational, definition, and process validation runs.
- Document and interpret study results with recommendations.
- Ensure commercialization of robust, compliant, and efficient processes and test methods.
- Work effectively in cross-functional teams, provide strong analytical skills for troubleshooting and root cause analysis, and communicate with internal and external team members. Serve as Subject Matter Expert (SME) for investigations.
- Provide input and rationale for critical process parameters.
- Utilize engineering fundamentals and process control strategies.
Qualifications:
- Bachelor's Degree or Advanced Degree in chemical or biochemical engineering with 4+ years of experience in large-scale process equipment design, scale-up implementation, and validation.
- Expertise in tablet, ointment, and liquid dosage forms used in pharmaceutical manufacturing.
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