Engineering Manager

il y a 7 jours

Alger, Alger, Algérie MS PHARMA Temps plein

Job Scope
The Engineering Manager Biosimilar project, is responsible for leading all engineering activities supporting biosimilar manufacturing operations. The role ensures facility readiness, equipment reliability, utilities performance, and engineering compliance throughout the product lifecycle, from project phase to commercial manufacturing.

Job Requirements
Education:
Bachelor's or Master's degree in Engineering (Mechanical, Electrical, Chemical, Biochemical, or related field).

Experience

  • 10+ years of experience in engineering within the pharmaceutical or biotechnology industry.
  • Strong experience in biologics or biosimilar manufacturing environments (sterile/aseptic is a strong plus).
  • Proven experience in leading engineering teams and managing complex projects.

Languages:
Fluency in English, French & Arabic (written and spoken)

Professional Knowledge

  • GMP & GDP regulations
  • Engineering systems for biologics (HVAC, clean utilities..)
  • Equipment qualification.
  • Facility design and layout for biosimilar manufacturing
  • Process equipment.
  • Maintenance strategies and reliability engineering
  • Project management
  • Health, Safety & Environment (HSE) standards
  • Change control, deviations, and CAPA systems

Main Competencies

  • Strong leadership and people management skills
  • Excellent problem-solving and analytical abilities
  • Strategic thinking and decision-making
  • Project management and planning skills
  • Cross-functional collaboration and communication
  • Continuous improvement mindset
  • Ability to work under pressure in regulated environments

Duties & Responsibilities

  • Lead and manage the Engineering Department supporting biosimilar manufacturing operations.
  • Ensure availability, reliability, and compliance of facilities, utilities, and production equipment.
  • Oversee engineering activities related to new projects, expansions, and technology transfers.
  • Manage equipment and utility qualification activities in coordination with Validation and QA teams.
  • Ensure compliance with GMP, safety, and regulatory requirements during all engineering activities.
  • Support manufacturing teams in troubleshooting equipment and process-related issues.
  • Participate in the design, installation, and commissioning of new equipment and facilities.
  • Lead change control processes related to engineering systems and infrastructure.
  • Support regulatory inspections and audits by providing technical documentation and responses.
  • Define preventive and corrective maintenance strategies to optimize performance and reduce downtime.
  • Manage engineering budgets, contractors, and service providers.
  • Develop engineering KPIs and continuous improvement initiatives.
  • Ensure compliance with HSE regulations and company policies.
  • Prepare periodic engineering reports and present updates to senior management.

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