Team Leader, Process Engineering

The Position

As a Team Leader, Process Engineering, you will play a critical role in our process engineering operations and contribute to continuous improvements to enhance efficiency, safety, and productivity. You will be responsible for promoting the smooth and efficient operation of our manufacturing processes. Core duties will include overseeing implementing process/safety improvements, providing support to the processing team, and equipment management.

Responsibilities

• Management
  • Provide leadership and guidance to a team of process engineers, ensuring their professional growth and development
  • Set clear performance expectations, provide regular feedback, and conduct performance evaluations
  • Foster a collaborative and inclusive work environment that encourages teamwork, creativity, and innovation
• Process Improvements
  • Identify areas for process optimization, efficiency enhancement, and cost reduction.
  • Analyze experimental data, identify trends, and make data-driven recommendations for process enhancements
  • Collaborate with cross-functional teams to translate experimental findings into actionable process improvements
  • Participate in process risk assessments and recommend mitigation strategies
• Safety
  • Participate in hazard and operability (HAZOP) studies and process safety assessments
  • Collaborate with manufacturing and safety teams to identify safety improvements
  • Maintain safety systems to ensure the process remains in a ready state and future safety issues can be prevented
  • Foster a culture of safety awareness and compliance throughout the production team
• Process Support
  • Act as point of contact for processes associated with production of oligonucleotide drugs; this includes but is not limited to solid-phase synthesis, traditional small-molecule chemistry, chromatography, tangential flow filtration, and lyophilization
  • Provide technical support for production operations, identify and resolve manufacturing issues
• Equipment Management
  • Support equipment and process qualification activities and ensure compliance with regulatory requirements
• Documentation Management
  • Manage the lifecycle of equipment documentation for production equipment; this includes but is not limited to P&IDs, Design Documentation, Validation Documentation, and Equipment Qualification Records (EQRs)
  • Implement P&ID change management processes, including version control and documentation updates
  • Manage the design and validation documentation for equipment to ensure compliance and design intent are maintained
• Additional Duties as required
  • Help develop batch records in a GMP environment
  • Occasionally assist with production work as needed

Requirements:

• Bachelor's degree in Chemical Engineering, or a related field
• Minimum four years experience in process engineering or a similar role within a manufacturing environment
• Proficient in data analysis tools and software
• Demonstrated leadership abilities with a track record of effectively managing teams and driving results
• Excellent problem-solving skills and the ability to apply analytical thinking to identify and resolve process-related issues
• Strong communication and interpersonal skills, with the ability to collaborate effectively across cross-functional teams
• Good verbal and written communication skills
• Excellent technical writing skills with high attention to detail

Preferred:

• Advanced Engineering Degree
• Experience working in a GMP setting with controlled documentation
• Strong knowledge of safety regulations, process optimization methodologies, and experimental design