Engineer I, MSAT
PMI Biopharma Solutions LLC
Nashville, TN
Engineer I, Manufacturing Science And Technology (MSAT)

Nashville, TN

PMI BioPharma Solutions is looking for an Engineering team member that is passionate and driven regarding his/her work. PMI BioPharma Solutions is in need of a motivated individual to provide their expertise in the delivery of results for the company and its clients.

Job Description

Reporting to the Associate Director of MSAT, the Engineer will be responsible for developing technical solutions in compliance with company and industry practices to meet user requirements. The ideal candidate will have industry experience working in a GMP manufacturing environment.

Responsibilities:
  • Manage technical aspects and coordinate tasks on assigned engineering projects from conceptual phases through equipment qualification and release
  • Design and execute process and equipment characterization studies with the goal of improving process capability, increasing production throughput and / or improving quality standards
  • Prepare reports, analyze data and make recommendations for improving process operations
  • Work as part of a cross-functional team to implement, maintain, troubleshoot and support process changes
  • Establish scientifically justifiable process control strategies for the manufacture of drug products for human use
  • Respond to equipment, utility or facility related issues, as required, in a cross-functional environment
  • Establish and maintain an engineering library for technical documents
  • Support Building Management System (BMS) for the monitoring of critical facility parameters
  • Support the design and construction of electrical cabinets for process controls systems
  • Perform Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) activities to confirm equipment operates and performs per specifications
  • Assist maintenance technician in the execution of preventive and corrective maintenance tasks on critical equipment, utilities and facilities
  • Support system owner by communicating and analyzing the necessary technical information toward the objective of making the right decision based on input from affected departments
  • Independently manage individual schedule and projects
  • Follow established procedures (SOPs) and provide compliant documentation for GMP activities
  • Make updates to site controlled drawing files through use of AutoCAD
Basic Qualifications:
BS in Biology, Biochemistry, Biotechnology, Microbiology, or Chemical Engineering
Excellent verbal and written communication skills

Preferred Qualifications:
2 – 5 years’ experience with BS in Pharmaceutical, Biological, Biotech, or related industry; hands-on experience in manufacturing operations or pilot lab / scale-up operations
Basic knowledge of Auto CAD drafting principles, practices and techniques
“PMI BioPharma Solutions is an equal opportunity employer and values diversity. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. PMI BioPharma Solutions does not discriminate on the basis of any status protected under federal, state, or local law.”