Senior Process Engineer, Sterile Drug Product

Eastridge Workforce Solutions is committed to connecting skilled professionals with meaningful career opportunities. We are seeking a Bio/Sterile Drug Product Process Expert to support our client’s team. Created/Revised Date: August 25, 2026 Anticipated Closing Date: September 25, 2026 Job Title: Bio/Sterile Drug Product Process Expert Location: Boston, MA – Hybrid preferred; Remote EST candidates considered Shift: Monday–Friday Hourly Pay Range and Other Compensation: $78.00–$87.75 per hour, depending on experience and qualifications. Employment Type: Full-Time | Temporary Contract – 1 year with potential extension FLSA Status: Non-Exempt Schedule: 40 hours/week; Boston candidates expected onsite 2–3 days/week. Up to 20% travel. 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. Benefits: Eastridge Workforce Solutions offers the following benefits, subject to applicable eligibility requirements. Use this link https://applicantcenterstorage.blob.core.windows.net/public-documents/EWSb1cb390e-729b-47eb-ab2f-b92adafbdd07-2024EplicaBenefitSummaryTempExternal.pdf to learn more about benefits available to Eastridge’s temporary employees. Due to the varying length(s) of temporary assignments, Eastridge Workforce Solutions’ Temporary Staff are not eligible for paid time off, unless required by applicable state law in which the position is based. However, from time to time Eastridge’s clients may offer additional benefits to Eastridge employees while on assignment. Information about those benefits will be communicated when applicable. Disclaimer: The compensation and benefits information in this posting represents Eastridge’s good faith and reasonable estimate of what it might pay for this position. Eastridge reserves the right to modify this information at any time, subject to applicable law. Equal Opportunity Employer: Eastridge Workforce Solutions is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity, and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, gender expression, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Eastridge Workforce Solutions also prohibits harassment or retaliation of applicants or employees based on any of these protected categories. It is our policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions. Please note that Eastridge is unable to provide visa sponsorship to applicants. Background Checks: Certain clients require Eastridge Workforce Solutions to perform background checks. Eastridge will consider qualified applicants with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the California Fair Chance Act, the Los Angeles City Fair Chance Ordinance, Los Angeles County Fair Chance Ordinance for Employers, and the San Francisco Fair Chance Ordinance. Massachusetts Candidates: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. 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