Our purpose is to bring hope to life by enabling life-changing therapies
for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.
The Engineer I provides support for biotechnology manufacturing by generating supportive documentation and
operational assistance of manufacturing. Working under the guidance of multi-departmental staff, individuals in this role take part in process transfer, resolving technical issues, and providing documentation to Manufacturing and Quality Assurance staff. The
Engineer I has a high degree of personal integrity and can work independently. The Engineer I continuously seeks subject matter experts’ knowledge and integrates that knowledge into MSAT processes.
ESSENTIAL JOB DUTIES/RESPONSIBILITIES
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Supports upstream and/or downstream Drug Substance commercialization and new product introduction assuring process fit to plant achieving right first-time
manufacturing in accordance with FDA/EMA/ICH
regulations/guidance.
·
Lead root cause investigations, writing and completing Quality investigations and corrective actions, such as CAPAs, CRs, and Deviations
·
Lead troubleshooting efforts in manufacturing operations. Provide technical leadership to Manufacturing and other departments associated with GMP
operations.
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Support/Lead resolution of deviations, investigations, and process issues.
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Develops and maintains strong relationships with Process Development (PD), Manufacturing, Quality Control (QC), Quality Assurance (QA), Engineering
(ENG) and Project management (PM) to support robust launch, commercialization and batch disposition.
·
Drive continuous manufacturing improvements for greater ease of use by collaborating with end-users on their departmental needs including the establishment
of metrics and KPI tracking.
·
Route MSAT documentation through Quality Management Software, and ensure that required documentation is reviewed and approved by key subject matter
experts in a timely manner
SKILLS
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Strong technical skills with an emphasis on applying the needs of end-users to manufacturing processes
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Strong collaborative skills with an emphasis on seeking the advisement and gaining the consensus of subject matter experts
·
Strong analytical problem solving skills to support technical transfer of new products
QUALIFICATIONS
Required:
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0-3 years of relevant industry experience
·
BS/MS in engineering
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Experience with GMP manufacturing or other scientific laboratories procedures
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Demonstrated proficiency with Microsoft applications
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Demonstrated proficiency in collaborating with various subject matter experts with effective communication skills necessary to interact with internal
stakeholders
Preferred:
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Experience with SharePoint
·
Experience with Quality Management Software, such as TrackWise Digital
·
Experience with Upstream and/or Downstream manufacturing operations and equipment
Compensation:
$66,960-$92,070
Josefine Fleetwood (She/Her), Employer Relations Manager
Oregon State University | College of Engineering
School of Chemical, Biological and Environmental Engineering
School of Nuclear Science and Engineering
Department of Biological and Ecological Engineering
116 Johnson Hall - Room 112
541-737-7286
Josefine.fleetwood@oregonstate.edu