Process Engineer II

Katalyst CRO; Framingham (MA); Hybrid; USD 90,000 - 120,000; Full time

Job summary

A leading company in the pharmaceutical manufacturing industry is seeking a Process Engineer II to join their team in Framingham, MA. This mid-senior level position involves providing expertise in dosage forms, engaging in cross-functional teams, and contributing to crucial process validations. The ideal candidate will have extensive experience and a strong educational background in chemical or biochemical engineering.

Benefits

Onsite parking available

Hybrid work model

Qualifications

• 10+ years of experience in large-scale process equipment design and validation.
• 5+ years experience for Bachelor's or 3+ years for Master's degree holder.
• Experience in pharmaceutical or biotech sector preferred.

Responsibilities

• Expertise in dosage forms for pharma manufacturing.
• Support development and validation studies.
• Document and interpret study results with recommendations.

Skills

Analytical skills

Troubleshooting

Root cause analysis

Communication

Technical assistance

Education

Bachelor's Degree in Chemical or Biochemical Engineering

Master's Degree

Job description

Join to apply for the Process Engineer II role at Katalyst CRO.

Responsibilities include:

1. Providing expertise in tablet, ointment, and liquid dosage forms used in pharma manufacturing. Offering technical assistance for process troubleshooting.
2. Working in cross-functional teams, utilizing analytical skills for troubleshooting and root cause analysis, and communicating effectively with team members. SME for investigations; knowledge of product serialization is a plus.
3. Contributing to critical process parameters, supporting development and validation studies, and leading planning for engineering and process validation runs.
4. Documenting and interpreting study results with recommendations to ensure robust, compliant, and efficient processes and test methods.
5. Possessing a Bachelor's or advanced degree in chemical or biochemical engineering, with 10+ years of experience in large-scale process equipment design, scale-up, implementation, and validation.

Requirements:

• Bachelor's Degree with 5+ years of experience or Master's Degree with 3+ years of experience.
• Experience with deviations, change orders, investigations, and root cause analysis.
• Previous pharma or biotech experience preferred.
• Knowledge of serialization is advantageous.
• Ability to work independently and as part of a team, with strong analytical skills.
• Hybrid work model, onsite 3 days/week, including either Monday or Friday.
• Willingness to relocate at own expense; possibility of extension.
• Onsite parking available; minimal exposure to chemicals or extreme temperatures.

Seniority level

Mid-Senior level

Employment type

Contract

Industry

Pharmaceutical Manufacturing