Senior Process Engineer

Company: BioPharma Consulting JAD Group
Location: Framingham
Posted on: May 13, 2022

Job Description:

BioPharma Consulting JAD Group has a great Senior Process Engineering role with an industry leader in Framingham, MA. The Senior Validation Consultant is expected to provide supports to the process engineering and validation departments. This is a temporary position (12 months) with the possibility of extension.

Responsibilities include, but are not limited to the following:

• Demonstrated ability to lead technical projects
• Establish continuous improvement strategies and lead the proposal, initiation, testing, and implementation of changes to cell culture and purification processes.
• Participate in Process Validation and Technology Transfer to internal or external manufacturing facilities.
• Author and/or review documents (technical memos, validation protocols, reports, etc.) related to process monitoring programs, at-scale or scale-down studies, annual product reviews, and non-conformances
• Collaborating with colleagues and floor staff in functional areas for the implementation of best practices, streamlining of operations, and equipment handling into SOPs and Manufacturing Batch Record.
• Communication of project status to Senior Leadership in multiple forums (as requested), maintaining the metric reporting for project performance
• Partner cross-functionally across the site to ensure maturity and execution of robust SOPs and alignment opportunities
• Provide timely and comprehensive progress of project scope and status updates to senior management
• Help to identify and coordinate a team to include all key partners and subject matter experts vital for roll out, and documentation adjustment process
• Basic Qualifications:
• Bachelor's degree in Engineering with 10 years plus of experience in the pharmaceutical and biotechnology industry
  
  Preferred Qualifications:
  
  • Project Management and Process Engineering skills and experiences
  • Experience leading cross-functional/site investigation teams in complex deviations including determination of potential product impact, root cause, and corrective and preventative actions
  • Experience in working with multiple, contending priorities in a fast-paced environment with minimal direction
  • Proven leadership traits
  • Excellent communication skills, both written and verbal (including technical writing and presentations) with ability to collaborate productively with technical and senior management staff
  • Ability to solve complex problems and make scientific risk-based decisions
  • Experience presenting to and interacting with representatives of regulatory agencies
  • Aseptic processing knowledge and/or practical experience

Keywords: BioPharma Consulting JAD Group, Framingham , Senior Process Engineer, Engineering , Framingham, Massachusetts