Filling Engineer - #1133130

KEY ACCOUNTABILITIES:

The Filling Engineer aims to be the SME for filling equipment, responsible for its full lifecycle management to ensure reliable equipment operation with optimized maintenance costs. Continuously identify and mitigate potential audit risks to achieve audit readiness as a routine practice for packing equipment.

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 coach maintenance technicians.

·       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).

·       Other tasks assigned by superior.

REQUIREMENTS: 

·       Minimum 5 years relevant maintenance management experience in pharmaceutical or related manufacturing.

·       Strong knowledge of GMP requirements and international standards.

·       Good communication, and cross-functional coordination skills.

·       Good analytical, troubleshooting, and decision-making capabilities.

·       Proficiency in English (written and spoken).