Project Engineer

Project Planning & Strategy

• Develop comprehensive project plans, including scope, objectives, timelines, resource allocation, and budget for plant expansion, equipment installation, and facility upgrades.
• Conduct detailed feasibility studies and risk assessments for proposed projects, presenting findings and recommendations to stakeholders.
• Collaborate with R&D, Production, Quality Assurance, and other departments to define project requirements and ensure alignment with business goals.
• Prepare and manage project documentation, including specifications, drawings, schedules, and reports, ensuring accuracy and completeness.
• Contribute to the strategic planning for long-term infrastructure and capacity enhancements within the pharmaceutical manufacturing facility.

Project Execution & Management

• Facilitate cross-functional team coordination, ensuring effective communication and collaboration among internal teams, contractors, and vendors.
• Implement robust project scheduling and timeline management techniques to ensure projects are delivered on time.
• Manage project budgets, tracking expenditures, identifying variances, and implementing corrective actions to ensure cost-effectiveness.
• Coordinate and oversee all project activities, including design, procurement, construction, installation, and commissioning.
• Lead the execution of assigned engineering projects from initiation to closure, ensuring adherence to project plans and performance metrics.

Compliance & Quality Assurance

• Prepare and submit necessary regulatory documentation and reports related to project installations and modifications.
• Implement robust quality control measures throughout the project lifecycle to minimize deviations and ensure high-quality outcomes.
• Conduct regular site inspections and audits to verify compliance with safety regulations, quality standards, and project specifications.
• Develop and execute validation protocols (IQ, OQ, PQ) for new equipment and systems, ensuring proper documentation and adherence to regulatory guidelines.
• Ensure all project activities and deliverables comply with Good Manufacturing Practices (GMP), regulatory requirements (e.g., USFDA, MHRA), and internal quality standards.

Vendor & Contractor Management

• Establish and maintain strong working relationships with key suppliers and service providers.
• Manage the procurement process for equipment and materials, ensuring timely delivery and cost-efficiency.
• Review and approve vendor proposals, technical specifications, and project deliverables.
• Oversee contractor activities on-site, ensuring adherence to safety protocols, project specifications, and quality standards.
• Identify, evaluate, and select qualified contractors and vendors, negotiating contracts and managing their performance to ensure project success.

Process Improvement & Optimization

• Collaborate with the production team to integrate new processes and equipment seamlessly into existing operations.
• Stay updated with the latest advancements in pharmaceutical manufacturing technologies and best practices to drive continuous improvement.
• Utilize engineering principles and problem-solving methodologies to troubleshoot operational issues and implement sustainable solutions.
• Evaluate existing processes and equipment, proposing upgrades or modifications to optimize performance and reduce costs.
• Identify opportunities for process improvements and implement innovative engineering solutions to enhance operational efficiency, safety, and product quality.

Reporting & Communication

• Provide technical guidance and support to junior engineers and project team members.
• Lead project review meetings, fostering an environment of accountability and problem-solving.
• Document all project-related decisions, changes, and approvals, maintaining a comprehensive audit trail.
• Communicate effectively with all project stakeholders, ensuring clear understanding of project objectives, scope, and timelines.
• Prepare and present regular project status reports to senior management and stakeholders, highlighting progress, risks, and mitigation strategies.

Safety & Environmental Stewardship

• Promote sustainable engineering practices and resource efficiency in all project designs and implementations.
• Participate in safety audits and incident investigations, contributing to a proactive safety management system.
• Ensure proper disposal of waste materials and adherence to environmental protection guidelines during project execution.
• Conduct thorough risk assessments for all project phases, implementing measures to mitigate potential hazards.
• Champion a strong safety culture, ensuring all project activities comply with company safety policies and relevant environmental regulations.