Project Manager (FCS-05) at Sanofi Aventis US LLC

Miskolc, North Hungary, Hungary -

Full Time

Start Date

Immediate

Expiry Date

13 Mar, 26

Salary

0.0

Posted On

13 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Project Management, GMP Compliance, Budget Monitoring, Risk Management, Stakeholder Communication, Technical Leadership, Installation Supervision, Validation Processes, Documentation Management, Team Management, Problem Solving, Decision Making, Training Organization, Collaboration, Process Improvement, Digital Tools Proficiency

Industry

Pharmaceutical Manufacturing

Description

Job title: Project Manager (FCS-05) Location: Csanyikvölgy, Miskolc Hiring Manager: Zoltán Kozári Job Type: Indefinite, full-time About the job The Project Manager is responsible for directing the project and ensuring timely completion within the budget, installing a solution that meets user requirements and is accepted and understood by users. They lead planning and implementation, ensuring compliance with conditions in cooperation with Sanofi Group DP, OSD & Pack Technical division and CSA site management. Lead and manage an end-to-end installation project of plastic free pharmaceutical packaging machines at SANOFI CSANYIK site, ensuring compliance with GMP standards, regulatory requirements, and customer specifications. This role is critical for delivering high-quality, validated packaging solutions for pharmaceutical products. Key Responsibilities Monitor project budget, timeline and risks (responsible for escalation to local, regional, and global program management in case of any budget issues). Develop a detailed project organization and plan. Define user requirements in collaboration with key users and ensure they are met. Track project progress (prepare regular progress plans as requested and reports). Manage project team, processes and tasks. Ensure collaboration and communication necessary for project execution. Handle documentation needs and documents required for project implementation. Responsible during the project for: Creating and approving user specifications. Supporting tender processes for project manufacturing machines/equipment. Approving and supporting tests, qualifications, validations, and related documents for project machines/equipment. Overseeing installation and commissioning of project machines/equipment at the site. Summarize and provide feedback on project lessons learned. 1. Project Planning & Preparation Develop and manage comprehensive project plans including timelines, resource allocation, and budget forecasts. Coordinate pre-installation activities such as site readiness checks, utility requirements, and cleanroom compliance. Organize FAT (Factory Acceptance Test) and ensure all documentation is complete before shipment. 2. Installation & SAT Supervise mechanical and electrical installation of plastic free packaging machines and associated equipment. Ensure proper integration with upstream/downstream systems (e.g., blister machines, cartoners, serialization units). Lead SAT (Site Acceptance Test) and ensure successful commissioning according to GMP standards. 3. Validation & Compliance Manage IQ/OQ/PQ qualification processes in collaboration with Quality Assurance teams. Ensure all activities comply with pharmaceutical regulations and customer-specific SOPs. Maintain accurate and complete documentation for audits and regulatory inspections. 4. Technical Leadership Provide technical guidance to installation teams and troubleshoot complex issues during setup. Manage installation team. Coordinate with automation engineers and ITS for software configuration and system connectivity. Ensure machine performance meets specifications for speed, accuracy, and product integrity. 5. Stakeholder Communication Act as the primary point of contact for customers throughout the project lifecycle. Conduct regular progress meetings and provide transparent status reports to internal stakeholders. Manage expectations and resolve conflicts related to timelines, scope, or technical challenges or manpower needs. Ensure proper cooperation among site project team members and stakeholders outside the site. Coordinate collaboration between site and external project members. Share information with colleagues and strive to maintain a productive work environment. 6. HSSE, Risk & Issue Management Early identify potential risks (technical, regulatory, logistical) and develop mitigation strategies. Respond promptly to installation delays or equipment malfunctions to minimize downtime. · Health, Safety, Security, Environment: Comply with occupational safety, fire safety, environmental protection, and asset protection rules and regulations. Warn colleagues and immediately report hazardous situations to superiors to reduce risk. Regularly check personal protective equipment before starting work and use it properly. In case of malfunction, error, or unexpected situation, warn colleagues, act as expected to resolve it, or report to a superior. Report accidents or near misses immediately. 7. Training & Handover Plan to organize operator and maintenance training sessions for staff jointly with assigned team leads. Ensure the preparation of a detailed handover documentation; make sure to include SOPs, maintenance schedules, and troubleshooting guides by vendor. · Documentation: Prepare and support project-related documentation according to regulations. GMP (Good Manufacturing Practice) Attend mandatory GMP training and acquire the necessary knowledge. Perform work according to valid quality assurance and GMP rules and procedures. About You Several years of significant experience in a Project Manager roles. Project management skills and knowledge. Ensure the preparation of a detailed handover documentation; make sure to include SOPs, maintenance schedules, and troubleshooting guides by vendor. Sticking to timelines and deadlines, Ability to manage multiple projects streams under strict timelines. High affinity for using digital/IT tools. Advantages: Knowledge of GMP. 5+ years in preferably multinational pharmaceutical packaging machinery installation and 5 years in manufacturing project management. Hands-on experience with plastic free packaging systems or similar modular packaging solutions. GMP training highly desirable. Knowledge of pharmaceutical packaging processes, serialization, and track & trace systems. Familiarity with validation protocols (IQ/OQ/PQ) and regulatory compliance. Technical Competencies: Strong communication and collaboration skills. Situational leadership. Good and fast decision-making and problem-solving ability. Creativity and innovation. High sense of urgency and sense of responsibility. Commitment to continuous process improvement. Ability and skills to properly communicate in English (with focus on project management). MS Office proficiency. Additional Requirements: Willingness to travel occasionally (internationally) Proficiency in project management tools (MS Project, SAP) and technical documentation. About Sanofi We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives. Why choose us? · Join a leading pharmaceutical company and contribute to improving health outcomes worldwide. · Be part of a company at the forefront of medical research and breakthrough therapies. · Thrive in an environment that values diversity of thought and background. · Work closely with global and local teams, gaining exposure to various aspects of the pharmaceutical business. #LI-EUR Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! Global Terms & Conditions and Data Privacy Statement Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube

Responsibilities

The Project Manager is responsible for directing the project, ensuring timely completion within budget, and leading the installation of plastic-free pharmaceutical packaging machines. They must ensure compliance with GMP standards and manage project teams and documentation throughout the project lifecycle.