MSAT Engineer I

JOB SUMMARY

The MSAT Engineer I provides support for biotechnology manufacturing by generating supportive documentation and operational assistance of Right First Time 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 MSAT Engineer I has a high degree of personal integrity and can work independently. The MSAT Engineer I continuously seeks subject matter experts’ knowledge and integrates that knowledge into MSAT processes.

ESSENTIAL JOB DUTIES/RESPONSIBILITIES

• 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.
• Support/Lead resolution of deviations, investigations, and process issues.
• 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

• Strong technical skills with an emphasis on applying the needs of end-users to manufacturing processes
• 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 the technical transfer of new products

QUALIFICATIONS

Required:

• 0-3 years of relevant industry experience
• BS/MS in engineering
• Experience with GMP manufacturing or other scientific laboratory procedures
• Demonstrated proficiency with Microsoft applications
• Demonstrated proficiency in collaborating with various subject matter experts, with effective communication skills necessary to interact with internal stakeholders

Preferred:

• 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