✦ Luna Orbit — Engineering (Non-Software)

Sr Engineer I, Manufacturing Sciences

at Biogen

📍 Research Triangle Park, NC Hybrid 💰 $98K – $127K USD / year Posted April 01, 2026
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Position Details

Salary $98K – $127K USD / year
Type Full-Time
Experience mid
Exp. Years 4+ years
Education Bachelor's degree in relevant scientific or technical fields
Category Engineering (Non-Software)

About this role

Senior Engineer I, Manufacturing Sciences provides SME-level technical expertise on single-use materials and extractables/leachables across the global manufacturing network. The role supports process optimization, regulatory documentation, and supplier/vendor audits, with on-site involvement during inspections and audits.

Key Responsibilities

  • Serve as SME for single-use raw materials and E/L program assessments
  • Support development of raw material control strategies
  • Lead continuous improvement for raw materials
  • Conduct investigations with lab experiments and supplier data
  • Own/Support global E/L studies and regulatory collaborations

Technical Overview

Focuses on raw material control strategies, monitoring technologies, material release, and risk assessments for biopharma manufacturing. Requires knowledge of polymers, chemistry, extractables/leachables, deviations, CAPAs, and regulatory expectations.

Ideal Candidate

The ideal candidate is a technically curious engineer with 4+ years in biopharmaceutical manufacturing, specializing in extractables/leachables and single-use technologies. They bring strong analytical skills, experience with deviations, CAPAs, regulatory documentation, and a track record of cross-functional leadership.

Must-Have Skills

Bachelor's degree in engineeringchemistrymaterials scienceor related field4+ years direct relevant experienceExperience with extractables and leachables studies and regulatory expectationsKnowledge of polymeric materialschemistryand single-use systemsExperience supporting deviationschange controlsCAPAsand regulatory documentation

Nice-to-Have Skills

Hands-on extractables and leachables experienceExperience with regulatory inspections and vendor auditsTechnical lead or SME experienceIndustry forum participation

Required Skills

Bachelor's degree in relevant scientific or technical fields4+ years experienceextractables and leachablessingle-use systemspolymeric materialschemistrydeviationsCAPAsregulatory documentationroot cause analysisregulatory inspectionsvendor audits

Hard Skills

Bachelor's degree in relevant scientific or technical fields4+ years directly relevant experienceScientific and analytical skills to evaluate plasticsPolymeric materialsChemistrySingle-use systemsDeviationsChange controlsCAPAsRegulatory documentationRoot cause analysisRegulatory inspectionsVendor auditsTechnical leadershipE/L studies

Soft Skills

Technical curiosityAnalyticalIndependent workCross-functional collaborationProactive problem solving

Industry & Role

Industry Healthcare & Medical
Job Function Provide technical leadership in materials science for biopharmaceutical manufacturing, focusing on E/L studies and supplier qualifications
Role Subtype Senior Engineer
Tech Domains Tableau, Power BI, SharePoint, SQL / PostgreSQL

Keywords for Your Resume

subject matter expertsingle-use consumablesextractables and leachablesE/Lraw materialsdeviationsCAPAregulatory documentationregulatory guidancesupplier auditsvendor auditsroot cause analysischange controlsNIRVCNprocess optimizationpolymeric materialschemistryregulatory inspections

Deal Breakers

Bachelor's degree in a relevant technical field, 4+ years of directly relevant experience, Willingness to work on-site during training, critical projects, audits

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