Senior Process Engineer, Sterile Drug Product

Job Summary

Eastridge Workforce Solutions is hiring an experienced Bio/Sterile Drug Product Process Expert to provide technical oversight of sterile drug products manufactured at external CMOs. This role will support aseptic manufacturing, technical investigations, process improvements, and regulatory activities.

Essential Duties and Responsibilities

• Provide technical oversight of sterile drug product manufacturing at external CMOs.
• Lead deviation investigations, change implementation, risk assessments, and continuous improvement.
• Support Continuous Process Verification and commercial manufacturing activities.
• Partner with Quality, Operations, Supply Chain, and external manufacturing teams.
• Author/review CMC-related content for regulatory filings.

Requirements

• BS with 6+ years or MS with 5+ years of relevant pharmaceutical experience.
• Strong sterile drug product and aseptic fill/finish expertise.
• Knowledge of GxP and regulatory requirements, including regulatory submissions.
• Experience working with CMOs/CDMOs and external partners.
• Knowledge of container closure systems, microbiology, and extractables/leachables.
• Experience with root-cause analysis tools and statistical software such as Minitab or JMP.
• Strong communication, analytical, and cross-functional collaboration skills.

Location & Schedule

Boston, MA – Hybrid preferred; Remote EST candidates considered. Monday–Friday, 40 hours/week; Boston candidates expected onsite 2–3 days/week. Up to 20% travel.

Pay

$78.00–$87.75 per hour, depending on experience and qualifications.

Benefits

Eastridge Workforce Solutions offers benefits subject to applicable eligibility requirements. Due to the varying length(s) of temporary assignments, Eastridge's Temporary Staff are not eligible for paid time off, unless required by applicable state law. From time to time, clients may offer additional benefits while on assignment.