Process Engineer II - III (Downstream Purification)

Role: Process Engineer supporting downstream bioproduction at a GMP manufacturing facility, focusing on process troubleshooting, validation, and continuous improvement in a sterile environment. Responsibilities: 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. Requirements: 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. Preferred: Master’s degree, experience with biologics or biosimilars, and exposure to process validation and equipment qualification. High-Value: Downstream bioprocessing, GMP compliance, process validation, equipment troubleshooting, process development, cross-functional collaboration, sterile manufacturing environment. Work Setup: Onsite in West Lebanon, NH, with some on-call support; travel up to 10%.