Process Engineer GMR Specialist
2 weeks ago
At Lonza, we are committed to delivering high-quality products and services that make a positive impact on people's lives. We are seeking a highly skilled and motivated Process Engineer GMR to join our team.
Key Responsibilities:- Provide technical support to the GMR and production teams to maximize quality and productivity of the capsule manufacturing process.
- Determine and specify optimum processing parameters for Gel preparation in the Gel Melt Room.
- Provide guidance, training, and technical information to production personnel.
- Support new product development and ensure batch production first time right.
- Control and proper utilization of consumables (Gelatin, Colors, Cleaning agents).
- Ensure Safety & GMP on GMR shop floor.
- Responsible for day-to-day GMR operations-related activities, including making daily, weekly, and monthly reports.
- Ensure updated SOPs are in place and in use, and initiate all required documents (incidents, deviations, validations, SOP compliance, etc.).
- Verify all process parameters meet requirements.
- Ensure all equipment health checks are done as per plan, and coordinate with other departments for any corrections in case of machine failure or utility disruptions.
- Follow up with the maintenance team and ensure necessary actions are taken and maintained as per GMP.
- Ensure daily trim and capsule grinding, sampling, and labeling of bags, and update stock trim in BCFT 1 system.
- Update new color formulas in BCFT 1.
- Read and follow the Production Schedule and plan new color development.
- Verify previous day's all melt cycle graphic information in SCADA, and report and do RCA if found any abnormality.
- Understand and apply cGMP guidelines in Gelatin Preparation Room, including labeling.
- Ensure daily verification of equipment, weighing balance, and RM storage at their location with proper labeling.
- Control and minimize waste of RM, including trim, recyclable capsules, gel, additives, and dyes to ensure cost-effective production.
- Maintain records of waste gel solution, trims, capsules, and ensure disposal as per SOP and guidelines.
- Maintain inventory supplies and take inventory of various items.
- Ensure changes, process improvement plans, revised procedures, and other changes are implemented in shift post-training and 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.
- Perform other jobs as defined by HOD and be part of change management in general.
- 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 and use of PPEs.
- Ensure general GMP guidelines are 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 systems are in place.
- 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.
At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. We offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
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