Project Engineer

Role & responsibilities

Project Planning and Execution:

• Collaborate with stakeholders to define project scope, objectives, and deliverables.
• Develop comprehensive project plans, budgets, and timelines.
• Coordinate project activities, resources, and subcontractors.
• Monitor project progress and resolve any issues that may arise.
• Ensure projects are completed on time and within budget.

Regulatory Compliance:

• Ensure all projects adhere to pharmaceutical industry regulations and quality standards.
• Work closely with regulatory affairs teams to obtain necessary approvals and certifications.
• Implement and document GMP (Good Manufacturing Practices) and other relevant guidelines.

Equipment and Facility Upgrades:

• Manage the installation and commissioning of new manufacturing equipment.
• Oversee facility upgrades, including HVAC systems, cleanrooms, and utilities.
• Ensure the maintenance and calibration of equipment to meet regulatory requirements.
• Ensure Process Equipment Installation, commissioning and validation.

Budget Management:

• Develop and manage project budgets, including cost estimates and forecasts.
• Identify cost-saving opportunities while maintaining quality and compliance standards.

Risk Management:

• Identify potential risks and develop risk mitigation strategies.
• Ensure safety protocols are followed throughout project execution.
• Address any safety concerns promptly.

Cross-functional Collaboration:

• Collaborate with cross-functional teams, including production, quality control, and maintenance, to ensure project alignment with business goals.
• Communicate project status, issues, and updates to stakeholders and senior management.

Documentation and Reporting:

• Maintain detailed project documentation, including project plans, progress reports, and compliance records.
• Prepare regular project status reports for management.

Preferred candidate profile

• Bachelor's degree in Engineering (Mechanical, or Electrical) is required. Master's degree is a plus.
• Proven experience of 8-10 years as a Project Engineer/ set up of projects & Operations in a pharmaceutical manufacturing environment.
• Strong knowledge of pharmaceutical manufacturing processes and equipment.
• Familiarity with GMP, WHO and other regulatory requirements.
• Excellent project management skills, including the ability to manage multiple projects simultaneously.
• PMP (Project Management Professional) certification.
• Experience with Lean Six Sigma methodologies.
• Knowledge of automation and control systems in pharmaceutical manufacturing.

Computer Skill -

rhythma.bhatia@wingspharma.com