Engineer, Drug Substance Bioprocessing/Process Development & Optimization – REMOTE (JP15073)

3 Key Consulting is hiring an Engineer for a consulting engagement with an unnamed direct client, a biopharmaceutical company. The role focuses on optimizing drug substance manufacturing business processes, developing process documentation and digital solutions, and supporting technology-transfer improvements and project delivery.

Responsibilities:

• Optimization of business processes related to Drug Substance pharmaceutical manufacturing, such as technology transfer
• Generate business process documentation such as Guidelines, job aids, templates, and Standard Operating Procedures (SOPs), with feedback from SMEs and management
• Collaborate with partner organizations to develop and deploy digital business process solutions to facilitate knowledge management and business process execution
• Support strategy development to identify tech transfer business process pain points and deploy solutions to improve processes
• Collaborating with multiple stakeholders to understand project timelines, create a project plan, and execute the project deliverables in a timely fashion
• Develop visualization dashboards to communicate OKRs, metrics, and process improvements. Deliver presentations to management and cross-functional partners

Requirements:

• Drug Substance Bioprocessing background required
• 2+ years Prior experience in process development/ /Process Engineering environment, clinical or commercial scale manufacturing, or tech transfer, with specific experience in the implementation, scale up, and support of biopharmaceutical manufacturing processes
• Experience leading or supporting process optimization/ continuous improvement projects
• Some understanding of regulatory and cGMP requirements
• Experience with project management
• Has the ability to manage projects independently, break down high level projects into smaller incremental tasks, and elevate relevant issues to project lead and line management
• Some experience with digital tools and/or data visualization software (e.g. Tableau, Spotfire, Smartsheet, Sharepoint, AI tools)
• Excellent written and verbal communication
• Able to adapt to changing business needs and operational requirements
• Experience with issue resolution and ability to influence across support organizations
• Bachelor's degree (Chemical Engineering, Bioengineering or Biotechnology, computer science, or other quantitative discipline)
• Enjoys tackling challenges, working in teams, and excels at organizing information from numerous sources to provide well-constructed deliverables
• High attention to detail and quality in work
• Ability to collaborate well cross-functionally between departments and work closely with team members to accomplish larger tasks
• Passion for proactively identifying opportunities and solutions through creative data analysis
• Intellectual curiosity with ability to learn new concepts/frameworks and technology rapidly as needs arise
• Ability to problem solve, conceptualize solutions independently, escalate issues appropriately, and integrate feedback
• Ability to ask clarifying questions and seek guidance when necessary
• Ability to manage multiple projects simultaneously and deliver results in a timely fashion
• Accountable, Self starter, and quick learner
• Bachelor degree and 2 years of experience
• Associate degree and 6 years of experience
• High school diploma / GED and 8 years of experience
• Master degree