USA-Process Engineer II (Engineering)

Process Engineer II (Engineering)
Framingham, MA
12 Months
Hybrid role

Notes: Hybrid, onsite 3 days per week, must include a Monday or Friday.
Open to candidates willing to relocate at own expense Possibility of extension.
Free Parking onsite.
No chemicals or exposure to severe heat or cold. Must have experience: BS Degree min of 5+ years of experience. MS Degree in of 3+ years of experience.
Experience with deviations, change orders, investigations, process for root cause analysis Strongly preferred, previous pharma or bio tech experience.
Nice to Have: Knowledge of serialization is a plus. Team player and also ability to work independently Strong analysis and ability to inquire further when needed or ask for support.

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.
• 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 runs. 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.

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

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