Responsibilities:

• Utilizing sound engineering principles to develop manufacturing process capabilities to ensure adequate material supplies to meet project objectives
• Coordination of the process engineering group to execute continuous improvement projects including the evaluation and implementation of process changes to improve product quality, decrease cost, and improve manufacturing efficiencies
• Designing and executing detailed experimental plans
• Lead initiation and closure of Quality System Elements supporting manufacturing operations including Change Control, CAPA and event investigation.
• Maintaining accurate, detailed documentation throughout all phases of process development
• Ensuring effective communication within the operations team and across all functions that engage in development and production activities
• Supervising the process engineering team staff, including integration of new hires, coordination of production staff and employee development
• Identify, troubleshoot, and resolve technical issues associated with manufacturing operations with input from other technical functions
• Creating a development production environment using current standards in Current Good Manufacturing Practices including lean operations, continuous improvement and monitoring and trending of operation efficiency

Requirements:

• BS/MS in a technical discipline (Engineering preferred)
• 7+ years’ experience in process development or manufacturing operations in Pharmaceutical, Medical Device, or other FDA regulated industry required
• 2+ years’ experience in employee management in a cGMP environment
• Demonstrated aptitude for ‘hands-on’ experimentation with an exemplary history as a “self-starter”
• Mastery of CGMP quality system elements including change control, root cause investigation and CAPA
• Demonstrated experience in DOE including experimental design, execution, data analysis and results summation
• Experience with early-stage product development and scale up in a cGMP environment is preferred
• Ability to summarize data and results for business and technical audiences
• Outstanding professional-interpersonal and relationship building skills, and influencing and negotiating skills
• Must enjoy and thrive in an entrepreneurial environment