Senior Process Engineer, Sterile Drug Product

Eastridge Workforce Solutions; Boston (MA); Hybrid; USD 107,000 - 121,000; Full time

Job summary

Eastridge Workforce Solutions is seeking a highly experienced Bio/Sterile Drug Product Process Expert to oversee sterile drug product operations at external CMOs. The role supports aseptic manufacturing, investigations, process improvements, and regulatory filings.

The position requires a BS (6+ years) or MS (5+ years) in pharmaceutical science, with strong knowledge of GxP, regulatory submissions, and experience collaborating with CMOs/CDMOs.

Qualifications

• 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.

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.

Skills

Sterile drug expertise

GxP knowledge

CMO/CDMO experience

Root-cause analysis

Minitab/JMP

Regulatory submissions

Microbiology

Container closure

Cross-functional collaboration

Education

BS or MS in pharma

Tools

Minitab

JMP

Job description

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.

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.

Privacy

Information collected and processed as part of your candidate profile, job application, resume, and/or any other information you choose to submit is subject to Eastridge’s Privacy Policy: https://www.eastridge.com/privacy-policy , as well as

Eastridge’s Pre-Use Notice of Collection and Automated Decision-Making Technologies: https://www.eastridge.com/data-collection-notice .

By applying for this position, you consent to being contacted by Eastridge Workforce Solutions and its agents or authorized service providers regarding employment opportunities, assignments, and the recruiting process. Communications may be by phone call, AI-assisted or AI-generated phone call (where permitted by law), automated text message (SMS), or email.

The purposes for these communications may include, but are not limited to, confirming your interest in available opportunities, scheduling interviews, conducting initial screening conversations, and collecting information relevant to your application.

Message frequency may vary. Standard message and data rates may apply depending on your mobile carrier. You may opt out of receiving text messages at any time by replying "STOP" to any SMS message. For additional information regarding our text messaging practices, please review our SMS Terms and Conditions at: https://www.eastridge.com/sms-terms-and-conditions . You may opt out of receiving e-mail by clicking the “Unsubscribe” button.

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