Project Construction, CQV and Startup Phase:
- Support installation, commissioning, equipment start-up activities, and execution of FAT/SAT and IOQ.
- Lead or support commissioning test, punch list closures, deviation/variations resolutions, and change controls related to filling equipment.
- Support for start-up batches, technical troubleshooting, and first-of-a-kind process runs.
- Act as key contact with equipment vendors, contractors, and service providers.
- Lead or support technical clarifications, engineering changes, and ensure documentation completion.
Operational Phase:
- Responsible for full lifecycle management of filling equipment:
- Troubleshoot technical issues during equipment operation, optimize efficiency of existing packaging production lines, and reduce failure rates.
- Document Breakdown Analysis (BDA) and lessons learned for equipment-related problems.
- Develop and optimize preventive maintenance and predictive maintenance plans to ensure equipment reliability.
- Prioritize spare parts classification and establish rational inventory levels for critical components.
- Act as the SME for filling equipment, create SME training programs, and coaching technician
- Collaborate with production and quality departments to ensure equipment meets process requirements and relevant regulatory standards.
- Continuously identify and eliminate potential audit risks to achieve audit readiness as a routine practice.
- Provide technical support during internal audits, FDA/EMA/HSA inspections, and client audits.
- Lead or support deviation investigations, CAPA development, change control, periodic reviews, and risk assessments (HAZOP, FMEA, CMMS updates).
- Ensure timely and accurate updates of system documentation (SOPs, Maximo job plans, equipment files).
