PI Health Sciences
Website:
pihealthsciences.com
Job details:
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.
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