Executive / Sr. Officer - Process Engineering (Indore Plant)

GUFIC BIOSCIENCES LIMITED; Indore District; On-site; INR 600,000 - 800,000; Full time

Job summary

GUFIC BIOSCIENCES LIMITED in Indore, India is seeking an experienced Engineering professional to plan and execute the engineering related activities across the injectable formulation facility. You will oversee operation, maintenance, and daily monitoring of electrical, utilities and process equipment, and support calibration, SOPs, and QA documentation in alignment with cGMP requirements.

The role involves coordinating with validation teams, engaging external service providers, driving

Qualifications

• Plan and execute engineering activities.
• Maintenance and troubleshooting of equipment and instruments in injectable formulation facility.
• Prepare URS, SOPs, PRs and technical recommendations per cGMP.
• Ensure SOP compliance and training of related personnel.
• Prepare preventive maintenance and calibration schedules.
• Maintain QMS documents (CCF, CAPA, Incident, QRM, QMS).
• Coordinate with validation team for equipment qualification and validation.

Responsibilities

• Plan and execute engineering activities.
• Oversee maintenance of electrical, utilities and process equipment.
• Coordinate with external service providers and manage service agreements.
• Identify energy-saving opportunities.
• Maintain online documentation and prepare for audits.

Job description

Responsibilities

• Responsible for the planning and execution of the Engineering related activities.
• Operation & maintenance and daily monitoring of Electrical, Utilities & Process Equipments (like HVAC, Water System, Electrical Equipments and Process areas Equipment’s etc.).
• Maintenance and troubleshooting of Equipment’s / Instruments of injectable formulation facility
• Preparation of URS, Standard Operating Procedures, Purchase Requisition and Technical Recommendation for Utilities & Process Equipment’s etc. as per cGMP requirements.
• Ensure compliance of SOP’s and all related SOP’s training to be imparted to all concern department personnel.
• Preparation, Review & Implementation of Preventive maintenance schedule and Instruments calibration schedule of all equipment’s & Instruments of Utilities, Process equipment’s etc.
• Responsible for preparation of QMS documents (e.g., CCF, CAPA, Incident, QRM, QMS etc.).
• Prepare the indent/PR & maintain the critical mechanical/Electrical/Instrumentation spares, chemicals and consumable materials etc. availability at site for avoid the breakdown time of utilities and Process equipment’s.
• Handling of external service provider agencies, preparation of service technical agreement and Bill checking and processing.
• Identify and Implementation of energy saving activities.
• Maintain online documentation and follow the SOP’s.
• Always readiness for represent of facility /Equipment / Documents for regularity audits.
• Responsible to coordinate with validation team for timely preparation/review of documentation & execution of all equipment’s, Qualification, requalification and validation activities. (Review of documents URS/DQ/FAT/SAT/IQ/OQ/PQ etc.).
• To maintain the document as per cGMP requirement.
• Preparation, Review & Implementation of drawings related to Plant, Machinery, Utility, HVAC etc.
• Responsible for compliance related to safety procedure, safety work place and achieve zero list time accident and compliance.