Subject Matter Expert - Plant Engineering Operations - Pharma

Responsibilities:

1. Provide subject matter expertise in the design, construction, and optimization of pharmaceutical facilities, ensuring adherence to industry standards and regulatory requirements.

2. Contribute to both front-end and detailed engineering phases, ensuring seamless transition from conceptual design to operational efficiency.

3. Conduct comprehensive analysis of pharmaceutical plant engineering processes, ensuring adherence to industry standards, including Current Good Manufacturing Practices (cGMP), and regulations.

4. Provide expert guidance on the design, construction, and optimization of pharmaceutical manufacturing facilities with a focus on cGMP compliance across various dosage forms, including tablets, liquids, softgels and injectables.

5. Collaborate with multidisciplinary teams to identify and address engineering challenges in plant operations, equipment, and facility maintenance, ensuring cGMP principles are integrated into all processes for diverse pharmaceutical products.

6. Bring hands-on experience in the manufacturing and packing processes of tablets, liquids, softgels, and injectables optimizing production efficiency while maintaining cGMP standards.

7. Design and oversee the implementation of clean rooms, ensuring compliance with industry standards and regulatory requirements.

8. Provide insights on the implementation of cGMP principles in API (Active Pharmaceutical Ingredient) projects, ensuring quality and regulatory compliance in various dosage forms.

9. Demonstrate extensive experience in micro and clean process design, emphasizing precision and compliance with cleanliness standards.

10. Utilize expertise in equipment sizing and selection, along with best value option analyses for resource and cost optimization in Pharma manufacturing.

11. Spearhead layout engineering projects, maximizing space utilization and workflow efficiency in the plant environment. Collaborate with cross-functional teams to assess and improve existing plant layouts, identifying opportunities for enhancement and streamlining.

12. Implement best practices in bulk material storage management and handling, warehouse design, QA labs, Sample booths, to enhance overall plant performance.

13. Utilize expertise in Building Information Modelling (BIM) to enhance design accuracy, improve collaboration, and streamline construction processes.

14. Implement and adopt best engineering quality assurance processes, ensuring the highest standards of quality and regulatory compliance in Pharma plant.

15. Lead efforts in plant automation, optimizing manufacturing processes through the seamless integration of automated systems.

16. Integrate lean construction principles to drive efficiency, reduce waste, and enhance the overall effectiveness of construction projects within the pharmaceutical manufacturing environment.

17. Stay informed about cutting-edge technologies in pharmaceutical manufacturing and recommend their implementation for enhanced efficiency across different dosage forms.

18. Review and contribute to the creation of technical documentation, including standard operating procedures, protocols, and validation procedures (IQ/OQ/PQ).

Requirements:

1. Degree in Engineering, Chemical Engineering, or a Mechanical Engineering

2. Extensive experience (15+ years) in a subject matter expert role within pharmaceutical plant engineering, with a strong focus on cGMP compliance and expertise in tablets, liquids, Injectables and softgel production.

3. Must have worked in leading Multinational / Indian pharmaceutical in India or overseas or leading pharma facility Engineering company

4. In-depth knowledge of pharmaceutical manufacturing processes, facility design, regulatory requirements, and cGMP principles across various dosage forms.

5. Expertise in the validation process of pharmaceutical manufacturing systems and equipment, with specific experience in tablets, liquids, Injectables and softgels.

6. Hands-on experience in the manufacturing and packing processes of tablets, liquids, injectables and softgels, optimizing production efficiency while adhering to cGMP standards.

7. Knowledge in construction management, incorporating lean construction principles, and utilizing Building Information Modelling (BIM).

8. Experience in clean room design and implementation, ensuring compliance with industry standards.

9. Strong analytical skills to assess and optimize engineering processes and systems while maintaining cGMP integrity.

10. Excellent communication and collaboration skills to work effectively with cross-functional teams, regulatory agencies, and project stakeholders.

11. Familiarity with industry-specific software and tools related to plant engineering, cGMP compliance, and construction management.

12. Proven track record of staying current with industry trends and advancements, especially in cGMP, validation processes, lean construction, and clean room design.

13. Certification in relevant areas (e.g., Professional Engineer license) is a plus.

Location: Chennai and Vadodara