Packaging Engineering Section Head At Viatris Egypt
Key responsibilities for this role include:
Works closely with Production to target maintainability issues, lower maintenance costs, and implement improvements.
Establishes the initial preventive maintenance for packaging equipment / instruments that are in accordance with the guidelines and specifications for that packaging equipment / instrument class.
Selects the initial Maintenance Strategy for new packaging equipment and provides updates to keep the strategy current.
Implements equipment reliability plans by ensuring job plans and tasks are established (Preventative Maintenance (PM), Predictive Maintenance (PdM), Corrective maintenance..)
Review preventive and corrective work order activities and provide equipment maintenance history review.
Performs root cause failure analysis of packaging equipment deficiencies, develops, changes, and/or initiates maintenance activities such as PM, Condition Based Monitoring (CBM), lubrication programs, training, and spare parts strategies to improve performance and equipment availability.
Updates packaging equipment reliability plans based upon Root Cause Failure Analysis results to further reduce the number of failures and minimize the effects of failures that do occur.
Hands on experience in pharmaceutical environment including regulatory requirements associated with 21 CFR Part 11 and supporting validation of control system equipment.
Participate in equipment/system-based Root Cause Failure Analysis (RCFA) investigations and update equipment reliability plans.
Partner with Production and Quality Team Leads on troubleshooting and scheduling.
Facilitate and participate in the investigation teams created to determine root cause of exemption reports, QARs and laboratory investigation reports. Serve as a liaison between quality, Operations and regulatory/Compliance to facilitate timely closure of investigations.
Based on investigation results, develops design modification projects to improve performance and initiates work orders or capital projects to complete.
Provide maintenance engineering input to Capital Project Engineering through packaging equipment selection review, PM / Calibration activity development, spare parts needs, and training requirements.
Train Technicians and Junior Engineers
Demonstrate knowledge in GMP, environmental, health and safety procedures to assure regulatory, policies and/or guidelines compliance.
Observe and notify any risk situation for the environment, health, or safety.
Develops and implements plant safety improvements.
To take all possible steps to ensure that all safety instructions measures are strictly followed.
Assure that all energy conservation initiatives comply with all regulatory agency requirements.
A good knowledge of track and trace system.
5+years of experience in packaging lines maintenance, projects and serialization.
A degree in Engineering (mechanical, electrical, mechatronics ) with an experience of packaging lines, checkweigher, tertiary packaging and serialization/aggregation systems.
Good command of English language.
Experience with Root Cause Failure Analysis, Equipment Criticality Ranking, PM/PdM optimization, and/or Failure Modes and Effects Analysis.
Strong organization, interpersonal, oral, and written communication skills.
Working knowledge of MS Office.
Knowledge of GMP and environmental regulations applicable to the pharmaceutical Industry.