Engineering project lead

The Engineering Project Lead is essential for overseeing the technical and engineering aspects of the project. This role ensures that all engineering tasks are executed in alignment with the project’s requirements, timelines, and regulatory standards. The Engineering Project Lead is responsible for coordinating with the suppliers and others project's stakeholders, troubleshooting technical challenges.

Key Responsibilities:

• Ensure that the end-to-end execution of ophthalmic pharmaceutical projects implementation, including commissioning, Qualification the new installation in accordance with the detailed project plan, timelines, and monitor progress to ensure timely delivery.
• Identify technical project risks and implement mitigation strategies to ensure smooth project progression.
• Ensure compliance with Good Manufacturing Practices (GMP) and other relevant regulatory standards.
• Manage vendor relationships and oversee procurement of equipment, materials, and services required for project execution.
• Facilitate communication among project Team, providing regular updates on project status and addressing issues proactively.
• Lead technical troubleshooting and problem-solving activities during development and manufacturing processes.
• Document project activities, results, and lessons learned in accordance with regulatory and quality standards.
• Support technology transfer activities from giving site to the receiving site.

Qualifications:

• University degree in: Electromechanics, Mechanics, Chemical Engineering, Pharmaceutical Engineering, Industrial Process Engineering, Biological or Biotech Engineering) master’s degree or higher preferred.
• Proven experience (10+ years) in pharmaceutical project management, preferably with a focus on ophthalmic/ sterile/Onco/ Injectable products.
• Strong understanding of pharmaceutical manufacturing processes, equipment, and regulatory requirements.
• Excellent leadership, communication, and interpersonal skills.
• Proficiency in project management tools and software.
• Knowledge of GMP, GLP, and FDA/EMA regulations related to pharmaceutical manufacturing.
• Ability to work collaboratively in a multidisciplinary team environment.

Preferred Skills:

• Experience with ophthalmic Sterile, Oncology or Injectable technology.
• Prior involvement in technology transfer and scale-up activities.
• Certifications in Project Management (PMP or equivalent).

This role offers an exciting opportunity to lead innovative ophthalmic pharmaceutical projects that improve patient outcomes.