Lead Process Engineer – CMO Operation Support

Lead Process Engineer – CMO Operation Support

Requirements

• B.S. in Engineering or Life/Pharmaceutical Sciences with 8+ years MSAT experience with CMO interactions, or M.S. in Engineering or Life/Pharmaceutical Sciences with 7+ years MSAT experience with CMO interactions
• Advanced understanding of regulatory and cGMP requirements
• Experience and track record of compliance in a highly regulated GMP environment
• Ability to apply complex engineering principles and statistical analysis, including design of experiments, in order to solve processing issues and evaluate opportunities for process improvements
• Advanced understanding of engineering controls and risk management
• Ability to manage project resources and elevate relevant issues to project lead and line management
• Demonstrated ability to work independently
• Ability to build and maintain high-performing, cross-functional partnerships and to lead matrix teams to advance complex projects to their completion
• Ability to multi-task and function in a dynamic environment
• Excellent troubleshooting skills
• Excellent written and verbal communication

Responsibilities

• Independently evaluates, selects and executes complex experimental, modeling and engineering techniques
• Conduct engineering projects from beginning to end, including development of project plan
• Responsible for protocols, reports and specifications. Compiles and analyzes data, document results, and review documentation
• Works cross functionally to enhance and improve processes
• Maintains, monitors and ensures highest quality in services or products
• Maintains advanced knowledge of industry trends and advancements
• Develops and implements best practices and processes
• Troubleshoots to resolve problems: root cause analysis, escalates issues as appropriate
• Works under general supervision, and operates with appreciable latitude for day to day routine matters
• May be assigned to a single, complex interdisciplinary research area or manage multiple moderately complex projects and assignments
• Executes work independently or could lead part of a team from a technical perspective
• Will train lower-level personnel
• Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. Networks with key contacts outside own area of expertise
• Contributes to the development of scientific & engineering concepts to achieve strategic objectives
• Generally initiates, directs and executes development studies through collaborative efforts and through individual efforts that may have long-term impact

Preferred Qualifications

No preferred qualifications provided.