Process Engineer GMR Specialist
3 weeks ago
At Lonza, we are a global leader in life sciences operating across three continents. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of.
As Process Engineer GMR Specialist, you will be responsible for providing technical support to the GMR & production team to maximize quality and productivity of capsule manufacturing process. You will determine and specify optimum processing parameters for Gel preparation in Gel Melt Room.
In this role, you will provide guidance, training, and technical information to production personnel. You will also provide support for new product development and ensure batch production first time right.
Key Responsibilities:
- Responsible for day-to-day GMR operations related activity, make daily, weekly, monthly reports.
- Ensure updated SOP in place and in use, initiate all the required documents.
- Verify all process parameters meet the requirement.
- Ensure all equipment health checkup done as per plan, coordinate with other departments for any correction in case of machine failure or utility disruptions.
- Ensure daily trim & capsule grinding, sampling & labeling of bags, update stock trim in BCFT 1 system.
- Update new color formula in BCFT1.
- Read and follow Production Schedule and do the planning of new color development.
- Verify previous day's all melt cycle graphic information in SCADA, if found any abnormality report and do RCA.
- Understand and apply cGMP guidelines in Gelatin Preparation Room including labeling.
- Ensure daily verification of equipment, weighing balance should be done.
- Ensure RM should be stored at their location, with proper labeling and if required to send to retesting.
- Control and minimize waste of RM including trim, recyclable capsule, gel, additives and dyes to ensure cost-effective production.
- Maintain record of waste gel solution, trims, capsules, ensure disposal of the material as per SOP and guidelines.
- Maintain inventory supplies and take inventory of various items.
- Ensure changes, process improvement plans, revised procedure and other changes are being implemented in shift post training and ensure these are consistently maintained.
- Ensure area in shift remains presentable in terms of cleanliness, organized form, documentation and systems.
- Maintain 5S in the area.
- Ensure audit readiness in GMR area.
- Do other jobs as defined by HOD and be part of change management in general.
Environmental, Health & Safety:
- Act in compliance with all laws, regulations and policies on safety and environment, give feedback, make inspections and implement and follow up corrections.
- Ensure safe working culture in shift including safe working habits, use of PPEs.
Quality:
- Ensure general GMP guidelines are being followed and motivate colleagues to do the same consistently.
- Responsible for in-process quality control of work in progress.
- Do follow-ups regularly to ensure system in place.
Key Requirements:
- Degree in B.tech/Mechanical/Diploma/B.Pharma.
- A work experience of between 4 years to 07 years in the similar role.
- Good Communication skills.
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