28 Aug
|
PI Health Sciences
|
Ahmedabad
28 Aug
PI Health Sciences
Ahmedabad
Job Description Job Summary: n 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. n n Key Responsibilities: n Project Planning & Execution n n Support the planning, scheduling, and execution of engineering and facility projects. n Coordinate project activities from conceptual design through procurement, installation, commissioning, qualification, and project closure. n Monitor project progress and ensure adherence to timelines, budgets, and quality requirements. n Identify and mitigate project risks, delays, and resource constraints. n n Engineering & Technical Support n n Assist in equipment installation, commissioning, qualification (IQ/OQ/PQ), and validation activities. n Participate in Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), and vendor evaluations. n Support preparation of User Requirement Specifications (URS), Design Qualification (DQ), risk assessments, and change control documentation. n Coordinate with internal stakeholders and external contractors/vendors to ensure smooth project execution. n n Documentation & Compliance n n Prepare and maintain project documentation including schedules, budgets, reports, meeting minutes, drawings, and engineering records.
n Ensure compliance with cGMP guidelines, engineering standards, EHS requirements, and regulatory expectations. n Support internal and external audits by maintaining accurate and complete engineering documentation. n Track project expenditures and assist in budget management and reporting. n n Stakeholder Coordination n n Work closely with Production, Quality Assurance, Quality Control, Validation, Maintenance, EHS, Procurement, and external partners. n Facilitate effective communication among project teams to achieve project objectives. n Provide timely project updates and progress reports to management. n n Continuous Improvement n n Participate in initiatives focused on improving project delivery, engineering processes, operational efficiency, and cost optimization. n Support implementation of best practices in project management and pharmaceutical engineering. n n Qualifications n n Bachelor's Degree in Mechanical Engineering. n 2-5 years of experience in Engineering, Projects, or Project Management. n Preferred experience in Pharmaceutical, Biotechnology, Healthcare, Chemical, or other regulated manufacturing industries. n n Required Skills & Competencies n n Understanding of project management principles and methodologies.
n Knowledge of pharmaceutical manufacturing processes and cGMP requirements. n Familiarity with engineering documentation, qualification, and validation concepts. n Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint). n Experience with Microsoft Project or equivalent project scheduling tools. n Exposure to project stores activities such as Material Receipt, GRN, Service Entry, and Inventory Coordination. n Strong analytical, problem-solving, and organizational skills. n Excellent verbal and written communication skills. n Ability to manage multiple priorities and work effectively in a cross-functional environment. n Solid documentation and reporting capabilities. n n Preferred Skills n n Exposure to AutoCAD and engineering drawing software. n Knowledge of HVAC systems, pharmaceutical utilities, cleanroom infrastructure, and manufacturing equipment. n Experience with SAP, ERP platforms, and project management systems. n Understanding of qualification and validation documentation. n Awareness of Lean Manufacturing, Six Sigma, and continuous improvement methodologies. n n Key Performance Indicators (KPIs) n n Timely completion of assigned project milestones. n Adherence to approved project budgets and schedules. n Quality and accuracy of project documentation. n Compliance with GMP, EHS, and regulatory standards. n Effective coordination with internal stakeholders and external vendors. n Successful support of equipment commissioning, qualification, and validation activities. n n
📌 Project Executive (Ahmedabad)
🏢 PI Health Sciences
📍 Ahmedabad