Process Engineer II - III; Downstream Purification

Process Engineer supporting downstream bioproduction at a GMP manufacturing facility, focusing on process troubleshooting, validation, and continuous improvement in a sterile environment.

• lead process and equipment troubleshooting, support deviations, CAPAs, equipment validation, process development, and implementation of process or automation improvements
• participate in design reviews for plant expansions and process changes
• ensure systems are maintained in validated states per regulatory standards
• manage projects including scope, risk assessments, and budgets
• provide cross-functional support across manufacturing, engineering, quality, and technical teams
• support audits and inspections
• mentor junior staff and oversee contractor activities
• participate in on-call support rotations

• Bachelor’s degree in engineering or related field
• 5+ years of experience in pharmaceutical or biotech process manufacturing, preferably in large-scale bioprocessing
• knowledge of GMP, regulatory compliance, automation systems
• strong communication skills
• ability to work in a fast-paced, team-oriented environment

• Master’s degree, experience with biologics or biosimilars, and exposure to process validation and equipment qualification

• Downstream bioprocessing
• GMP compliance
• process validation
• equipment troubleshooting
• process development
• cross-functional collaboration
• sterile manufacturing environment

• Onsite in West Lebanon, NH, with some on-call support
• travel up to 10%