Job description
Biocon is seeking an experienced Senior Engineer to join our Drug Product Engineering team. This role offers the opportunity to contribute to cuttingedge pharmaceutical manufacturing while driving excellence in validation, maintenance, and compliance.
Key Responsibilities
- Review and approve project documents, timelines, and schedules.
- Support commissioning and validation activities (FAT, SAT, DQ, IQ, OQ, PQ).
- Execute qualification activities and ensure timely completion.
- Oversee preventive maintenance, spare parts availability, and equipment reliability.
- Review and approve QMS documents; support audits and CAPA closure.
- Collaborate with vendors for site services and repairs.
- Lead improvement initiatives in equipment, process, and quality systems.
- Manage team training, shift scheduling, and departmental objectives.
Requirements
- Bachelor's degree in Mechanical, Electrical, Chemical, or related Engineering discipline.
- 57 years of experience in pharmaceutical/biotech manufacturing or engineering.
- Strong knowledge of validation protocols and QMS systems.
- Handson experience with preventive maintenance and equipment qualification.
- Familiarity with SAP and data management tools is an advantage.
- Excellent leadership, communication, and problemsolving skills.
