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Contract TypeContract TypeFull-time
Workplace typeWorkplace typeOn-site
LocationLocationRiyadh

About the Role

Saudi Biotechnology Manufacturing Company (SAUDIBIO), a leading biopharmaceutical company and insulin manufacturer in Saudi Arabia, is seeking a highly experienced Engineering and Maintenance Manager. This full-time position is based at its facility in Hawtat Sudair, Riyadh, and is crucial for ensuring the efficient and compliant operation of its state-of-the-art sterile fill and finish facility.

Role Overview

The Engineering and Maintenance Manager will be responsible for planning, directing, and implementing all aspects of engineering activities. This includes the maintenance, calibration, and automation of production and auxiliary equipment. The role requires a strong understanding of Good Engineering Practices (GEP), safety, environmental, and quality standards within the pharmaceutical and biotechnology manufacturing industries.

Key Responsibilities

  • Manage engineering operations by planning and directing all engineering activities within the facility.
  • Develop and implement policies and procedures for the implementation, maintenance, and calibration of production and auxiliary equipment.
  • Establish procedures for maintenance, calibration, automation, and monitoring of equipment performance.
  • Create procedures for the planning, installation, operational/performance testing, and change control of equipment in accordance with Good Engineering Practices (GEP).
  • Ensure the implementation of safety, environmental, and quality practices and procedures as outlined in organizational guidelines, SOPs, and applicable regulations.
  • Maintain the engineering staff by recruiting, selecting, orienting, and training employees, including GMP procedures.
  • Ensure engineering staff understand and follow established aseptic/sterile procedures and GMP procedures while supporting manufacturing activities.
  • Assist the Validation Department in establishing master validation documents, including Validation Master Plans, Building Master Plans, Equipment and Utility Validation Plans, IQ/OQ/PQ, risk assessments, and gap assessments.
  • Consult with manufacturing, production, and quality departments on the selection of new equipment and the build-up or modification of plants or rooms.
  • Maintain engineering staff results through coaching, counseling, and disciplining employees, and by planning, monitoring, and appraising job results.
  • Achieve financial objectives by preparing the engineering budget and scheduling expenditures.
  • Provide technical leadership in planning, executing, and managing engineering projects.
  • Prepare periodic reports for all engineering and maintenance activities.
  • Actively participate in running projects and provide required support to project managers for new company projects from an engineering perspective.
  • Implement operational excellence through efficient plant design and ensure continuous improvement in process, cost, quality, and production.

Qualifications and Requirements

  • Bachelor's degree in an engineering field, automation, or any other related field.
  • A minimum of 10 years of experience in the Pharmaceutical/Biotechnology Manufacturing industries.
  • Knowledge in Pharmaceutical/Biotechnology Manufacturing is essential.
  • Proficiency in ERP and engineering software.
  • Demonstrated leadership capabilities.
  • Experience in coaching and counseling staff.
  • Proven ability in recruiting and training employees.

Required Skills

  • Engineering Operations Management
  • Maintenance Planning
  • Equipment Calibration
  • Automation
  • Monitoring Equipment Performance
  • Installation
  • Operational/Performance Testing
  • Change Control
  • Good Engineering Practices (GEP)
  • Safety Practices
  • Environmental Practices
  • Quality Practices
  • Standard Operating Procedures (SOPs)
  • Good Manufacturing Practices (GMP) Procedures
  • Aseptic/Sterile Procedures
  • Validation Documentation
  • Risk Assessments
  • Gap Assessments
  • Equipment Selection
  • Plant/Room Modification
  • Budgeting
  • Expenditure Scheduling
  • Project Management
  • Technical Leadership
  • Reporting
  • Operational Excellence
  • Continuous Improvement
  • Pharmaceutical/Biotechnology Manufacturing
  • ERP Software
  • Engineering Software
  • Certified Six Sigma belt (preferred)
  • Total Maintenance Management (preferred)

Work Environment and Schedule

This is a full-time position located in Hawtat Sudair, Riyadh, Saudi Arabia. The standard working days and hours are Sunday to Thursday, from 8:00 AM to 5:00 PM.


Requirements

  • Requires +10 Years experience

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