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 & ExecutionSupport 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 SupportAssist 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 & CompliancePrepare 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 CoordinationWork 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 ImprovementParticipate 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.QualificationsBachelor'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 & CompetenciesUnderstanding 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.Solid 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 SkillsExposure 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.

📌 Project Executive (Gujarat)
🏢 PI Health Sciences
📍 Gujarat