Manufacturing Process Engineer

Organization: PQE Group

Location: 
Chicago IL
US

Commitment: 
Full Time, Contract

Description: 

Full Job Description

  • Serve as MSAT representative on client project teams.
  • Actively support process optimization and implementation of strategies for improving Upstream/Downstream unit operations throughout the product lifecycle.
  • Provide resolution of deviations, investigations, and process issues.
  • Network with Process Development, Manufacturing, and Quality team members to ensure reliable state to process control, and drive continuous improvements.
  • Participate in review and analysis of manufacturing campaign data trending, and present daily progress, as well as end of campaign summary updates.
  • Support emergent events response for on-floor manufacturing issues.
  • Generate and maintain documents related to GMP Manufacturing executions, product impact assessments, and campaign summary reports.
  • Define and provide user requirements for process equipment associated with multiple facilities for the manufacture of biologic Bulk Drug Substance(s).
  • Provide technical leadership to Manufacturing and other departments associated with GMP operations.
  • Serve as the process Subject Matter Expert; provide input when troubleshooting processes on the manufacturing floor and during post-operational investigations
  • Participate in the project team meetings, decisions, and creation of milestones representing MSAT.
  • Prepare and present data associated with manufacturing processes to internal and external clients.
  • Maintenance of Process Control Strategy
  • Process training, as needed, in adherence to company policies and quality requirements.

Knowledge, Skills & Abilities

  • · Must be self-motivated, organized and proactive.
  • · Demonstrated ability to interface/communicate extensively with internal and external clients.
  • · Ability to coordinate multi-departmental tasks and deliverables (interaction with Process Development, Engineering, QA, QC, etc.).
  • · Proven experience successfully managing multiple projects simultaneously.
  • · Demonstrated ability to build effective working relationships across departments (QA, Process Development, Project Management and Business Development) to support new processes and products.
  • · Demonstrated experience leading troubleshooting efforts.
  • · Ability to provide technical training to others on GMP manufacturing operations.
  • · Strong communication skills necessary to interact with internal stakeholders.
  • · Strong presentation skills.
  • · Expertise in relevant math, science and engineering disciplines.
  • · Thorough knowledge of GMP regulations (ICH Q7A) as it applies to job function.

Education/Experience

  • · BS in Biochemistry, Chemistry, Biology or other relevant discipline required; MS in related discipline preferred.
  • · 3+ years’ relevant experience from the pharmaceutical industry working in a cGMP environment.
  • · Advantage with relevant experience bringing biotechnology equipment and processes from design through GMP operational readiness.
  • · Must have experience with and demonstrated understanding of Good Manufacturing Practices (GMP) and applicable regulations (e.g., ICH Q7A, 21 CFR Part 211, etc.).
  • · Must have experience writing, reviewing and approving GMP documentation.
  • · Advanced computer skills including Excel and Word.

Job Types: Full-time, Contract

Schedule:

  • Monday to Friday

Education:

  • Bachelor's (Preferred)

Work Location:

  • Fully Remote
Minimum Education: 
Bachelors degree