Project Executive

PI Health Sciences Ltd · Gujarat, India

Job Summary:

We are seeking a dynamic and detail-oriented Executive Engineer - Engineering & Projects to support the planning, execution, monitoring, and successful completion of engineering and capital projects within a pharmaceutical manufacturing environment. The role involves coordination with cross-functional teams to ensure projects are delivered safely, on time, within budget, and in compliance with cGMP, regulatory requirements, and company quality standards.

Key Responsibilities:

Project Planning & Execution

• Support the planning, scheduling, and execution of engineering and facility projects.
• Coordinate project activities from conceptual design through procurement, installation, commissioning, qualification, and project closure.
• Monitor project progress and ensure adherence to timelines, budgets, and quality requirements.
• Identify and mitigate project risks, delays, and resource constraints.

Engineering & Technical Support

• Assist in equipment installation, commissioning, qualification (IQ/OQ/PQ), and validation activities.
• Participate in Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), and vendor evaluations.
• Support preparation of User Requirement Specifications (URS), Design Qualification (DQ), risk assessments, and change control documentation.
• Coordinate with internal stakeholders and external contractors/vendors to ensure smooth project execution.

Documentation & Compliance

• Prepare and maintain project documentation including schedules, budgets, reports, meeting minutes, drawings, and engineering records.
• Ensure compliance with cGMP guidelines, engineering standards, EHS requirements, and regulatory expectations.
• Support internal and external audits by maintaining accurate and complete engineering documentation.
• Track project expenditures and assist in budget management and reporting.

Stakeholder Coordination

• Work closely with Production, Quality Assurance, Quality Control, Validation, Maintenance, EHS, Procurement, and external partners.
• Facilitate effective communication among project teams to achieve project objectives.
• Provide timely project updates and progress reports to management.

Continuous Improvement

• Participate in initiatives focused on improving project delivery, engineering processes, operational efficiency, and cost optimization.
• Support implementation of best practices in project management and pharmaceutical engineering.

Qualifications

• Bachelor's Degree in Mechanical Engineering.
• 2-5 years of experience in Engineering, Projects, or Project Management.
• Preferred experience in Pharmaceutical, Biotechnology, Healthcare, Chemical, or other regulated manufacturing industries.

Required Skills & Competencies

• Understanding of project management principles and methodologies.
• Knowledge of pharmaceutical manufacturing processes and cGMP requirements.
• Familiarity with engineering documentation, qualification, and validation concepts.
• Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
• Experience with Microsoft Project or equivalent project scheduling tools.
• Exposure to project stores activities such as Material Receipt, GRN, Service Entry, and Inventory Coordination.
• Strong analytical, problem-solving, and organizational skills.
• Excellent verbal and written communication skills.
• Ability to manage multiple priorities and work effectively in a cross-functional environment.
• Strong documentation and reporting capabilities.

Preferred Skills

• Exposure to AutoCAD and engineering drawing software.
• Knowledge of HVAC systems, pharmaceutical utilities, cleanroom infrastructure, and manufacturing equipment.
• Experience with SAP, ERP platforms, and project management systems.
• Understanding of qualification and validation documentation.
• Awareness of Lean Manufacturing, Six Sigma, and continuous improvement methodologies.

Key Performance Indicators (KPIs)

• Timely completion of assigned project milestones.
• Adherence to approved project budgets and schedules.
• Quality and accuracy of project documentation.
• Compliance with GMP, EHS, and regulatory standards.
• Effective coordination with internal stakeholders and external vendors.
• Successful support of equipment commissioning, qualification, and validation activities.