22 Aug
|
PI Health Sciences
|
Junagadh
22 Aug
PI Health Sciences
Junagadh
Job Summary: /n We are seeking a energetic 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.
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- Coordinate project activities from conceptual design through procurement, installation, commissioning, qualification, and project closure.
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- Monitor project progress and ensure adherence to timelines, budgets, and quality requirements.
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- 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.
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- Participate in Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), and vendor evaluations.
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- Support preparation of User Requirement Specifications (URS), Design Qualification (DQ), risk assessments, and change control documentation.
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- 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.
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- Ensure compliance with cGMP guidelines,
engineering standards, EHS requirements, and regulatory expectations.
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- Support internal and external audits by maintaining accurate and complete engineering documentation.
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- 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.
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- Facilitate effective communication among project teams to achieve project objectives.
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- 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.
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- Support implementation of best practices in project management and pharmaceutical engineering.
/n /n Qualifications /n /n
- Bachelor's Degree in Mechanical Engineering.
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- 2-5 years of experience in Engineering, Projects, or Project Management.
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- 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.
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- Knowledge of pharmaceutical manufacturing processes and cGMP requirements.
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- Familiarity with engineering documentation, qualification, and validation concepts.
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- Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
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- Experience with Microsoft Project or equivalent project scheduling tools.
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- Exposure to project stores activities such as Material Receipt, GRN, Service Entry, and Inventory Coordination.
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- Strong analytical, problem-solving, and organizational skills.
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- Excellent verbal and written communication skills.
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- Ability to manage multiple priorities and work effectively in a cross-functional environment.
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- Strong documentation and reporting capabilities.
/n /n Preferred Skills /n /n
- Exposure to AutoCAD and engineering drawing software.
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- Knowledge of HVAC systems, pharmaceutical utilities, cleanroom infrastructure, and manufacturing equipment.
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- Experience with SAP, ERP platforms, and project management systems.
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- Understanding of qualification and validation documentation.
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- Awareness of Lean Manufacturing, Six Sigma, and continuous improvement methodologies.
/n /n Key Performance Indicators (KPIs) /n /n
- Timely completion of assigned project milestones.
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- Adherence to approved project budgets and schedules.
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- Quality and accuracy of project documentation.
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- Compliance with GMP, EHS, and regulatory standards.
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- Effective coordination with internal stakeholders and external vendors.
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- Successful support of equipment commissioning, qualification, and validation activities.
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📌 Project Executive (Junagadh)
🏢 PI Health Sciences
📍 Junagadh