46 applicants

Overview

Company

Original Job Post

Stevanato Group · 2 days ago

Project Manager

Fishers, IN

Full-time

Onsite

Mid Level

3+ years exp

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Health CareManufacturing

Hiring Manager

Marcelino García de León

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Responsibilities

Construction, assembly, expansion, and modification of new civil, industrial, and particularly productive buildings.

Construction, assembly, expansion, and modification of clean rooms from ISO 8 to ISO 5.

Design, installation, and commissioning of new utility systems.

Design, installation, commissioning, and validation of new pharmaceutical systems (PW, WFI, PSG, HVAC).

Design, installation, and commissioning of special systems (e.g., Automated Warehouse).

Analysis and proposals for improvements in energy saving.

Coordinate multifunctional teams typically composed of Production, Logistics, Equipment, QA, Regulatory, Suppliers, Facilities, and potentially R&D.

Develop performance specifications for engineering companies.

Develop specifications for industrial plants and URS for pharmaceutical plants.

Develop “User Requirements Specifications” in collaboration with other involved roles.

Develop, manage, and monitor project Gantt charts, identifying and implementing corrective actions as necessary.

Develop project budgets and manage project accounting.

Technically, commercially, and financially oversee suppliers during design, implementation, assembly, test runs, validation, and documentation delivery.

Oversee FAT, SAT, IQ, OQ, PQ activities.

Qualification

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Project ManagementTechnical Regulations KnowledgeGMP Regulations KnowledgeISPE Regulations Knowledge

Required

Bachelor's degree in engineering (chemical, industrial processes, mechanical, energy, etc.)

3-5 years of experience in project management in similar positions (plants, clean rooms, utilities)

Knowledge of relevant technical regulations (e.g., civil and urban planning norms, installation norms)

Knowledge of relevant GMP (Good Manufacturing Practices) and ISPE (International Society for Pharmaceutical Engineering) regulations

Company

Stevanato Group

Founded in 1949, Stevanato Group is one of the world's largest providers of integrated containment and delivery solutions for the biopharmaceutical industry.

Founded in 1949

Veneto, Veneto, ITA

5,001-10,000 employees