Process Engineer

Job Purpose

Lead and support operations teams to maintain appropriate standards and drive improvements in manufacturing and development processes.

Key Responsibilities

• Collaborate with both internal and external customers, suppliers, and agencies to define and enhance manufacturing and development procedures.
• Optimize manufacturing and development operations continually.
• Identify and implement opportunities for process improvements.
• Support capital project implementations.
• Serve as the process lead for inspection development activities.
• Lead technical problem-solving and root cause analysis across manufacturing operations with cross-functional teams.
• Establish and monitor performance metrics to track effectiveness.
• Drive initiatives to reduce cycle times alongside manufacturing teams.
• Apply and promote best practices consistently.
• Design, conduct, and implement plant trial and process development programs.
• Challenge existing operational standards to foster continuous improvement.
• Effectively manage multiple tasks and prioritize workload.
• Ensure all quality documentation remains compliant and up to date.
• Act as a subject matter expert supporting new product introductions and enhancement projects.
• Provide resources and expertise for clinical supply provision projects.
• Apply knowledge within aseptic or oral dose manufacturing environments.
• Be a subject matter expert on product quality attributes and critical process parameters.
• Plan and execute experimental programs.
• Operate process laboratories effectively.
• Participate in scale-up and technology transfer projects.
• Coordinate with teams on clinical supply provision and new formulation programs.
• Support complaint management, laboratory control records, deviations, and corrective actions ensuring timely and effective resolutions.
• Achieve specific measurable goals focused on process improvements.
• Reduce process cycle times.
• Maintain strict compliance with current Good Manufacturing Practices (cGMP) at all times.

Qualifications and Skills

• Degree in Chemical, Industrial, or equivalent Engineering discipline required.
• Advanced degrees in Pharmaceutics, Pharmacy, or related sciences considered advantageous.
• Technical expertise in aseptic manufacturing and lyophilisation is a plus.
• Proficient in design of experiments and relevant statistical methods.
• Comprehensive understanding of the pharmaceutical product development lifecycle.
• Excellent technical report writing and verbal communication skills.
• Lab and pilot plant operational experience.
• Strong research, innovation, and creativity capabilities.
• Competent project management skills.
• Structured and statistical problem-solving skills.