Process Engineer / Scientist

The Fountain Group; Framingham, Town of Oyster Bay (MA, NY); On-site; USD 80,000 - 100,000; Full time

Job summary

An established industry player is seeking a skilled Process Engineer / Scientist to join their team in Framingham, MA. This role involves overseeing and improving manufacturing processes in a dynamic biopharmaceutical environment. You will provide technical leadership, ensuring compliance and efficiency while addressing production challenges. The ideal candidate will have a strong background in downstream purification and be adept in regulatory requirements. This is a fantastic opportunity to contribute to innovative projects and advance your career in a supportive, onsite setting.

Qualifications

• 7 years of experience in downstream purification in a commercial setting.
• Familiarity with regulatory requirements and cGMP concepts.

Responsibilities

• Provide technical leadership and oversee manufacturing processes.
• Assist in designing new processes and facilities for production.

Skills

Downstream purification

Chromatography

Filtration

Viral clearance

Process monitoring

cGMP concepts

Education

Bachelor's degree

Master's degree

PhD

Tools

AKTA

HPLC

LIMS

MES

Distributed Control Systems

Job description

Currently, I have an opening for a Process Engineer / Scientist located in Framingham, MA. Details for the position are as follows:

Technical Information:

• Pay: $80-90 hourly, depending on experience level
• Onsite, M-F, 8am-4:30pm (Fully ONSITE!)
• 12-month contract with potential for extension or conversion

Qualifications:

• Bachelor's (7 years), Master's (5 years), or PhD (3 years) of experience in downstream purification in a commercial setting, including AKTA, HPLC, Filtration, UF/DF, Chromatography, Viral clearance, and leachable and extractables.

Job Description:

• Manufacturing Science partners with biologics manufacturing operations and oversees manufacturing processes, ensuring they are capable, compliant, in control, cost-effective, and continuously improved.
• Provide technical leadership at manufacturing sites, including process monitoring, CPV, root cause investigation, change assessment, debottlenecking, and continuous improvement.
• Anticipate, respond to, and resolve issues that arise during production.
• Assist in designing new processes and facilities, with expertise in scale-up, manufacturability, PAT, capacity analysis, and cost analysis.
• Support documentation for regulatory purposes and stay current with regulatory requirements affecting manufacturing processes, implementing changes as needed.
• Experience with biologics downstream unit operations, including Filtration, UF/DF, Chromatography, Viral clearance, and leachable and extractables.
• Understand cGMP concepts and be familiar with the quality and regulatory framework.
• Knowledge of computerized systems in biopharmaceutical manufacturing, such as Distributed Control Systems, Process Data Historian, LIMS, and MES.