Senior Process Engineer, Pto

Vetamc

Process and equipment comparisons
New raw materials introduction
Development studies
Supports or leads new product introductions to the site by conducting process and equipment comparisons, new raw materials introduction, development studies, clinical supplies manufacturing, cleaning processes development/validation and training of technicians as required

Job Summary

  • Supports or leads new product introductions to the site by conducting process and equipment comparisons, new raw materials introduction, development studies, clinical supplies manufacturing, cleaning processes development/validation and training of technicians as required.
  • Provides technical guidance in support of site and divisional capital projects and new facility start-up activities, ensuring that the process design is well thought-out and robust for routine manufacturing.
  • Provides technical expertise related to the product, equipment and manufacturing/cleaning processes in response to deviations/ product complaints/ adverse events to identify point of occurrence, root cause and corrective/ preventative actions.

Matching Summary

Supports or leads new product introductions to the site by conducting process and equipment comparisons, new raw materials introduction, development studies, clinical supplies manufacturing, cleaning processes development/validation and training of technicians as required.

Skills & Requirements

Must-have

  • Process and equipment comparisons
  • New raw materials introduction
  • Development studies
  • Clinical supplies manufacturing
  • Cleaning processes development/validation
  • PPQ protocols and reports
  • Technical writing for change requests
  • Experiment design and execution
  • Process design for routine manufacturing
  • Deviation and complaint investigation
  • Audit and regulatory support
  • Product portfolio management
  • Quality risk assessments
  • Change control management
  • Equipment qualification
  • Process validation
  • Cleaning validation/monitoring
  • Quality by Design (QbD) principles
  • Routine supply manufacture support
  • Production Systems tools utilization
  • Process parameter monitoring
  • Critical quality attributes monitoring
  • Continued Process Verification
  • Annual Product review activities
  • Statistical and risk analysis tools
  • Product CPP, CQA, Cpk knowledge
  • Raw materials and PCC knowledge
  • Collaboration and best practices sharing
  • Environmental, Health & Safety (EHS) leadership
  • Process hazards analyses (PHA)
  • Process Safety Management (PSM) activities
  • SOPs, gap analyses, and procedures development

Nice-to-have

  • Minimal guidance required
  • Proactive issue identification
  • Independent technical input
  • Knowledge transfer to colleagues
  • Active site product steward
  • Value Chain Technical Team member
  • Leadership behaviors alignment
  • Personal career development leadership

Key Requirements

  • Bachelors, Masters or Ph.D. degree in a technical field
  • 3 to 5 years technical experience in pharmaceutical manufacturing industry
  • Adaptability
  • cGMP Guidelines
  • Continuous Process Improvement
  • Electronic Batch Records
  • Laboratory Experiments
  • Mammalian Cell Culture
  • New Product Development
  • Organizational Performance Management
  • Personal Initiative
  • Pharmaceutical Manufacturing
  • Pilot Plant Operations
  • Process Engineering
  • Process Optimization
  • Product Development
  • Product Formulation
  • Production Management
  • Product Lifecycle
  • Product Portfolio Management
  • Quality Risk Assessment
  • Risk Assessments
  • Safety Management
  • Standard Operating Procedure (SOP) Writing
  • Sterile Manufacturing
  • Teamwork

Work Rights

Not specified

Tailored Resume

Cover Letter