Process Engineer II

• Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
• We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Job Description:

• Expertise in tablet, ointment, and liquid dosage product forms used in pharma manufacturing.
• Provide technical assistance to manufacturing and quality operations for process troubleshooting.
• Ability to work in cross functional teams, provide strong analytical skills for troubleshooting and root cause analysis, and communicate with internal and external team members.
• Subject Matter Expert (SME) for investigations. Knowledge of product serialization preferred.

Responsibilities:

• Ability to provide input and rationale for critical process parameters. Responsible for continuous improvements, support execution and documentation of development and/or validation studies and lead in the planning of engineering, investigational, definition and process validation run.
• Document and interpret study results with recommendations. Assure commercialization of robust, compliant, and efficient processes and test methods.
• Ability to utilize engineering fundamentals and process control strategies.

Requirements:

• Bachelor's Degree/Undergraduate Degree or Advanced Degree in chemical or biochemical engineering.
• Advanced degree in sciences with 10+ years large scale process equipment design, scale-up implementation & validation experience.
• Years of Experience: 4-8.
• BS Degree min of 5+ years of experience.
• MS Degree in of 3+ years of experience with deviations, change orders, investigations, process for root cause analysis Strongly preferred.
• Previous pharma or bio tech experience.
• Knowledge of serialization is a plus.

All your information will be kept confidential according to EEO guidelines.