Process Engineering Deputy Manager

Role & responsibilities

Process engineering JD (Peptide Process) Assistant / Deputy / Associate - Manager

• Perform and lead risk assessment exercises in support of Peptide process scale up & validation activities.
• Collaborate with R&D to ensure successful Peptide product development and technical transfer to Manufacturing.
• Coordinate Scale up & validation activities including, but not limited to, protocol training, execution by validation and other departments, data collection, deviation resolution, and CAPA initiation, in support of assigned validation projects.
• Maintain knowledge and comprehensive understanding of peptide regulations and current interpretations affecting equipment, product, and process
• Scale up & Validation representative on site project team and resource to other departments for Peptide product and process knowledge.
• Develop specialized technology/unit operations knowledge and provide training to operations as content expert for manufacturing standard operating procedures (SOPs).
• Perform troubleshooting and investigation on unexpected issues. Own equipment related deviations, CAPAs and changes. Lead or participate in investigations, problem-solving activities such as root cause analysis, FMEA, problem analysis and in development/implementation of countermeasure for quality, safety, environmental events.
• Provide Peptide process technical expertise for requirements, design, selection, installation, qualification, operation, maintenance, and reliability of process equipment and facilities.
• Perform and summarize improvement opportunities in technical reports, investigations, plant/lab trials, data analysis and process modelling.
• Active participation and engagement in the meetings and activities of the assigned process team and safety/environmental sub teams.
• Ensure process complies with current industry regulatory expectations, new regulations, and corporate policies and programs for Quality, Health and Safety & Environmental, Process Safety.

Qualification – B.Tech – Chemical Engineering

Experience – At least (5-8) year of relevant experience in Peptide synthesis and Purification Experiences in Peptide Process development & scale-up and capacity planning

• Knowledge in following unit operations: Lyophilization / Prep HPLC / Peptide Synthesizer / Nano filtration / Distillation Spray drying / Purification / Filtration / Automation
  
  

Additional Skills/Preferences:

• Strong written and oral communication skills
• Strong leadership and organizational skills
• Knowledge in managing multiple project objectives or assignments
• Technical Writing

*Location - Base location is in Bangalore. Must be willing to implement the work in our manufacturing unit in Vizag and travel to other work sites as and when required.