Process Engineering Support

Validation & Engineering Group, Inc. is a leading services supplier providing solutions for various industries including Pharmaceutical and Biotechnology. They are seeking a Process Engineering Support professional to provide technical support throughout the project lifecycle and engage in various engineering and compliance activities.

Responsibilities:

• Independently support technical discussions
• Evaluate equipment solutions
• Participate in capital projects
• Understand C&Q expectations
• Interact with multiple stakeholders
• Provide technical support throughout the project lifecycle
• Equipment assessment
• Capital project development
• Design review
• Installation support
• Verification activities
• Change controls
• Investigations
• Continuous improvement initiatives
• Supporting manufacturing process engineering activities
• Providing technical recommendations and evaluate engineering solutions
• Supporting capital project execution
• Development of project scopes
• Technical evaluations
• Equipment procurement support
• Review of vendor documentation
• Review of design drawings and technical specifications
• Installation support
• Supporting equipment verification activities
• Supporting Change Controls
• CAPA implementation
• SOP updates
• Engineering documentation revisions
• Participating in investigations and problem-solving activities
• Strong understanding of GMP documentation practices

Requirements:

• Bachelor's degree in Engineering (Chemical, Mechanical, Biomedical, Industrial, or related engineering discipline)
• Advanced technical background in pharmaceutical manufacturing, process engineering, or equipment lifecycle management preferred
• Minimum 5+ years of experience supporting engineering activities within the Life Science / Pharmaceutical / Biotechnology industry
• Experience working in GMP-regulated manufacturing environments
• Experience supporting equipment lifecycle activities, capital projects, process improvements, or manufacturing support initiatives
• Experience supporting manufacturing process engineering activities, including: Process improvements, Equipment replacement projects, Manufacturing support activities, Technical assessments, Problem-solving activities
• Ability to provide technical recommendations and evaluate engineering solutions
• Experience supporting equipment assessments, replacement strategies, and Business Continuity Planning (BCP) activities
• Experience supporting capital project execution, including: Development of project scopes, Technical evaluations, Equipment procurement support, Review of vendor documentation, Review of design drawings and technical specifications, Installation support
• Experience reviewing engineering documents such as: Equipment datasheets, Design drawings, Process documentation, Technical specifications
• Knowledge of Commissioning, Qualification, and Validation (CQV) processes
• Experience supporting equipment verification activities, including: User Requirements Specifications (URS), Design Reviews, Verification Strategies, Installation Verification (IV), Operational Verification (OV)
• Experience with electronic qualification systems; Kneat experience preferred
• Experience supporting: Change Controls, CAPA implementation, SOP updates, Engineering documentation revisions, Technical assessments
• Ability to participate in investigations and problem-solving activities, including: Root Cause Analysis (RCA), FMEA / PFMEA, Problem Analysis
• Strong understanding of GMP documentation practices
• Strong technical problem-solving skills
• Ability to work independently and manage multiple priorities
• Strong communication skills with technical and non-technical stakeholders
• Ability to provide clear project status updates, identify risks, and escalate issues
• Comfortable working onsite as required
• Experience supporting Fermentation and/or Purification manufacturing processes
• Experience with pharmaceutical manufacturing equipment and utilities
• Experience coordinating activities with: Manufacturing, Quality Assurance, Engineering, EHS, Vendors / Contractors
• Experience supporting field implementation activities and equipment installation projects
• Kneat qualification platform, Veeva Quality Docs, GECMS, GMARS, Microsoft Project / Excel / PowerPoint