Role: Process Engineer

Industry Type: Pharmaceutical & Life Sciences

Department: Production, Manufacturing & Engineering

Employment Type: Full Time, Permanent

Role Category: Engineering

Desired Candidate Profile : B.Tech (Chemical) / B.E (Chemical) / Diploma (Chemical) with 2-5 yrs of experience

Time: 9:00- 15:00 Hrs , 27th August 2023

Venue: Aurigene Pharmaceutical Services Limited, Bollaram Road, Miyapur, Jaya Prakash Narayan Nagar, Miyapur, Telangana 500049.

For any help regarding walk in drive on 27th August’23, You can reach out to us on – [email protected]

Roles and Responsibilities

• Monitoring of plant batches in shifts and generating data to correlate batches with lab scale.
• Coordinating with documentation team for preparation of plant documents after technology transfer.
  Equipment verification for scale up based on the PE team inputs as well as data generated in lab and literature.
• Support for CCF initiation and providing technical justification if required PE team inputs.
• Work with engineering team to plan, procure and qualify new process equipment/pipeline modifications to meet the process capability requirements that are required to execute GMP scale up batches.
• Support for review of batch related documents like trial & validation protocols, trial & validation reports and incident investigation reports etc.
• Support to drive incident investigations and to provide technical inputs for closure.
• Coordinating with cross functional teams to meet delivery of the project.
• Updating status of the project on timely basis during execution of the project to team.
• Coordinating with PE team for preparation of campaign reports after completion of the project.
• Collect the literature and attend trainings to evaluate process and powder safety data generation and interpretation.
• Coordinate with team for preparation of risk assessment, PSI and PHA prior to batch execution at scale.
• Providing support to MSAT R&D for Cylindrical experiments and lab activities for use test as well as investigation experiments.
• Providing support to implement the production plan to ensure on time deliveries.
• Maintaining shift wise daily project update tracker.
• Ensuring all Raw materials at shop floor before batch start up as per required quantities.
• Ensure pre-cleaning, PCO, ECR cleaning for all equipments.
• Follow up with team to close safety related action points and queries.
• Ensure with production team to submit internal communication(IC) in given time line to QC to keep inline for analysis.
• Ensure all accessories, packing material as per PE team recommendations.
• Coordinating with team to provide samples from MSAT R&D and Warehouse as per protocol or NRGP.
• To ensure process and cleaning validations are performed as per schedule and monitor the critical process parameters.
• Ensure storage of materials under proper storage conditions till time of use.
• To ensure the batches are produced as per cGMP, Production plan and meeting the dispatch targets.
• Providing support for handling of change controls & reporting, investigation of all product failures/deviations and take necessary correction, corrective action and preventive actions.
• Follow SOPs for all production activities.
• Ensuring recommended storage and packing conditions for all raw materials, Intermediates and finished products.
• Any other ad-hoc duty as requested by the team lead.

Note : Kindly bring your last three months salary slips and latest salary revision letter and 3 Passport size photograph