Process Development Engineer

Top Required Technical Skills

• Process Development & Validation
• Design of Experiments (DOE)
• Process validation
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Technical Manufacturing Validation (TMV)
• Statistical Analysis
• Experimental design and data analysis
• Data-driven decision making
• Advanced Problem Solving
• Root cause analysis
• Process troubleshooting
• Continuous improvement methodologies

Key Responsibilities

• Design, develop, analyze, troubleshoot, and provide technical expertise during research and product development activities.
• Lead process characterization and validation efforts to establish robust, scalable manufacturing processes.
• Design and execute studies to investigate critical technical and scientific questions.
• Apply statistical methods and DOE techniques to optimize process performance and product quality.
• Translate research findings into practical and commercially viable solutions.
• Drive resolution of complex technical issues through structured problem-solving methodologies.
• Develop and implement improvements to processes, systems, and products to enhance performance and reliability.
• Lead and manage complex technical projects, ensuring delivery of project objectives on schedule.
• Collaborate with cross-functional teams including R&D, Quality, Manufacturing, Regulatory, and Operations.
• Provide technical guidance, coaching, and mentorship to engineers and junior team members.
• Represent the organization as a technical lead for key projects, interacting with internal and external stakeholders as needed.
• Ensure compliance with applicable quality systems, regulatory requirements, and company procedures.

Education Required

• Advanced degree (Master's or PhD preferred) in Physics, Mechanical Engineering, Materials Science, Chemistry, Chemical Engineering, or Biomedical Engineering, or related technical/scientific field.

Experience

• Minimum 5 years of relevant experience with an advanced degree.
• Experience in process development, characterization, and validation within a regulated industry.
• Demonstrated expertise applying DOE and statistical analysis tools.
• Strong background in technical problem solving and root cause investigations.
• Experience leading complex technical projects with minimal supervision.
• Knowledge of project management principles preferred.

Career Level

• Specialist
• Career Stream: Technical Expert

Career Stream

• This role is intended for an experienced individual contributor recognized as a technical expert within their specialty.
• The position requires independent decision-making, leadership of major projects, and the ability to influence technical direction and business outcomes through specialized expertise.

Success Factors

• Deep technical expertise in process development and validation.
• Strong statistical and analytical capabilities.
• Ability to solve complex, ambiguous technical challenges.
• Excellent communication and stakeholder management skills.
• Proven leadership in cross-functional project environments.
• Ability to mentor and guide technical team members.
• A proactive mindset focused on innovation, quality, and continuous improvement.