Manufacturing and Supply
Where the
miracles of
science are made
a reality for patients

Job title: Qualification Specialist

Location: Cairo Site

Hiring Manager: Reliability & Maintenance Manager

About the job
We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Job Purpose

The Maintenance and Reliability team is the cornerstone in the site, we are dedicated to ensuring the continuous, safe, and efficient performance of all plant equipment and systems. Our team leverages a proactive approach, utilizing advanced reliability engineering principles and data-driven strategies to minimize downtime and maximize productivity.

The Maintenance and Reliability Manager is a critical leadership role responsible for ensuring the overall reliability and efficiency of the plant's equipment and systems. This position will develop and implement a comprehensive site reliability program, manage maintenance activities for optimal value, cost-effectiveness, and safety, oversee spare parts and service provider management, drive continuous improvement initiatives, and manage calibration and qualification programs.

Main responsibilities

• Create Calibration Management Program according to Sanofi Guidelines and Directives.
• Perform risk assessment studies for all items or instruments in the plant to define items subjected to calibration.
• Create Calibration Plan and Qualification Plan.
• Arrangement and Support Calibration activities performed by third party contractors when needed Supervise Activities executed by contractors and review final reports generated by them
• Calibration of all critical instruments in the site using standard calibrated devices according to calibration management program, sticking to the approved annual plan and/or after Repairs.
• Issuing Calibration Certificates for calibrated items.
• Create IQ, OQ and PQ Protocols for Equipment and Systems in the site and Execute Qualification studies for equipment (Production Machines, Autoclaves, Tunnels, Ovens, Incubators, Refrigerators and Cold Stores… etc.) and HVAC system according to the approved qualification plan and/or after Repairs.
• Establishment of a database for all equipment and machines in the site including manufacturer, model, serial number, and qualification status to evaluate capacity and support CAPEX need in co-operation with maintenance Dept.

HSE Responsibilities:

• Ensures HSE approval on any SOP that requires certain HSE precautions.
• Ensures HSE approval on any change.
• Follow the laboratory safety procedures
• Commitment to the appropriate PPE use.
• Follow the approved HSE policy and requirements.
• Following the statutory legislation concerning Health, Safety and environmental law.
• Hydrocarbons/ hazardous substance & waste segregation in accordance with approved waste management system.

HSE Responsibilities in case joining HSE Excellence team:

• Facilitate and guide the employees to implement the HSE&En. Policies.
• Implement all applicable standards and guides of Sanofi-Aventis in his/her area.
• Ensure from complying with all legal and Sanofi-Aventis requirements.
• Lead his/her team to implement the HSE & EnMS PASS.
• Train his/her team on HSE & EnMS procedures, SOP’s and MSDS.
• Report any accidents/incidents in his/her area to the HSE department.
• Lead his/her team for investigate accidents/incidents to define the root cause.
• Support the area manager for takes the corrective and preventive actions to eliminate reoccurrence of any Environmental or Energy nonconformance.
• Support the area manager for takes the corrective and preventive actions to eliminate reoccurrence of any accident/incident.
• Sharing for HSE / EnMS inspection program, take the corrective actions for any violations in his/her area.
• Lead the team of his/her area for doing full risk assessment and Environmental aspects studies.
• Define and control the required PPE’s for his/her area.
• Define the list of CMR and its operational control for Quality labs and production areas.
• Control the first aid kits in his/her area.
• Leading his/her team for control the significant hazards /aspects and Energy use.

Others:

• Perform other duties as assigned.
• Respect of company’s values, code of ethics and social charter.
• Respect of personal data protection charter.

Requirements/Qualifications

Experience

• >3 years in Microbiology\Chemistry \ Mechanical Engineering and HVAC experience.

• Strong background in mathematics, physics, and engineering
  Education

• Bachelor degree of Microbiology\Chemistry or any related field degree.

• Bachelor degree of Mechanical Engineering.

  Soft skills

• Good communication & Presentation skills.

• Highly motivated with ability to work independently

• Extremely proactive – capable of identifying and filling gaps

• Excellent interpersonal skills

• Very strong coordination and planning skills – proven track record essential

• Planning & organizing skills.

• Problem solving skills.

• Report writing skills.

• Ability to co-ordinate several inter-departmental activities.
  Technical skills

• Good technical skills, such as using calibration software, equipment, and tools.

• Familiar with the principles and methods of calibration, as well as the standards and regulations.  

• Good Engineering Practice (GEP).

• Good Manufacturing Practice (GMP).

• Good Documentation Practices (GDP).

• Good command of MS Word. Excel & Power Point.

• Languages: English

PursueProgress. Discover Extraordinary.

Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!