Position – Principal Engineer, Project
Company – BAXTER
Location – Ahmedabad, Gujarat
This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
Purpose of the Role:
This Position will ensure that all cGMP Manufacturing processes are designed and executed in a compliant and efficient manner. This role is intimately involved with the technical and regulatory aspects of all assigned projects from inception to completion. Lead, direct, and control all process engineering activities to develop manufacturing and production processes that are reliable, cost-effective, and support the organization’s short and long-term business objectives. Lead complex, or difficult process engineering Projects. Liaise with other senior executives across the organization to ensure that process engineering recommendations and plans are integrated with other parts of the business and aligned with the overall corporate objectives.
- Responsible for the Process Execution job of the project as per the requirement of the organization.
- To install and commission the new machines, equipment and parts and documenting it as per the guideline. E.g. Design Qualification, Installation Qualification, Operational Qualification and performance qualification.
- To study of drawings and evaluating the BOQ for the procurement of materials.
- To analyze OEE reports to find out improvement areas to run the plant in most efficient manner.
- To evaluate new process changes by R&D lab & implementation of same in plants.
- Provide technical support to all GMP Manufacturing processes; IQ/OP/PQ
- Develop manufacturing processes with cross functional groups to enhance and improve overall production
- Recommend, specify and order equipment in support of specific projects including setup and qualification as well as writing and executing qualification protocols
- Write, review and approve SOPs, specifications and other procedure as required
- Analyze, inspect, plan and evaluate use of space and facilities including HVAC systems, computer network wiring lighting and other factors
- Oversee coordination of building space allocation, layout and communication services
- To follow up with contractors for proper execution as per drawing maintaining the quality standards.
- To ensure and maintain the machine and equipment in satisfactory operating condition.
- To Investigate quality failure, process incident and Implementation of effective CAPA with site quality team
- To prepare of P & ID, Process flow diagrams of plant & equipment layouts & data sheets
- To carry out safety studies e.g. SHE Risk Assessment, HAZOP, QRA, JSA (Job Safety Analysis, MSA (Machine Safety analysis, Occupied building report), Quality Studies E.g. Quality Risk Assessment, cGMP design requirements & implementation.
- To keep track on budgeted yield and solvent recovery for meeting budgeted RMC.
- To co-ordinate and carry out development and basic design engineering activities of existing active ingredient.
- To carry out VOC Emission, pollution Load calculations, heat transfer study and heat requirement calculations.
- To eliminate Process Defects & maximize the production.
- To ensure the online documentation of all the relevant records of the department.
- To ensure team building & training to the technicians, operators and production staff for machines in the clean room areas and to attend their queries on immediate basis.
- Technical expertise in the areas of process controls, mechanical systems and design
- Knowledge of innovative manufacturing technologies and regulatory requirements
- Strong in Project Design and documentation
- Well versed with project qualification and validation
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [email protected] and let us know the nature of your request along with your contact information.