Catalyx is seeking a Project Manager to join our team in Philadelphia, PA.

Who We Are

Catalyx specializes in the science of operational processes. With a footprint across North America and Europe, the company carefully automates and services R&D, production, packaging, and delivery processes—globally—with a sophisticated blend of products, technologies, and lifecycle services. The company was formed in 2022 after CXV Global (Crest Solutions, Xyntek, and VistaLink) and Panacea Technologies joined forces. For over three decades, Catalyx’s partnership-based culture has helped organizations in production-intense, highly regulated industries optimize their operational efficiency, performance, and safety. To learn more about the company's experience and comprehensive suite of capabilities and solutions, visit www.catalyx.ai

The Role:

Catalyx is a trusted partner in delivering world-class lifecycle services to regulated and high-risk end markets. With a relentless commitment to innovation and excellence, we partner with life science and other highly regulated organizations, to empower them to enhance efficiency, and drive success. As part of this commitment, we are continuously developing our on-site teams to support the advancement of customer operations.

We are seeking an experienced Project Manager with a strong background in the pharmaceutical industry, particularly in validation and change control. The ideal candidate will be responsible for managing and coordinating multiple projects while ensuring compliance with regulatory requirements and industry best practices.

Responsibilities:

• Oversee the planning, execution, and completion of validation and change control projects.
• Develop and implement project plans, timelines, and resource allocation strategies.
• Ensure compliance with GxP regulations, FDA, EMA, and other industry standards.
• Manage change control processes, ensuring that all modifications are assessed, approved, and documented properly.
• Coordinate with cross-functional teams, including Quality Assurance (QA), Regulatory Affairs, Manufacturing, and Engineering.
• Monitor project progress, identify risks, and implement mitigation strategies.
• Prepare and present project status reports to stakeholders and senior management.
• Facilitate validation activities, including IQ, OQ, PQ, and process validation.
• Maintain documentation and ensure audit readiness.

Requirements:

• Bachelor’s/Master’s degree in Pharmaceutical Sciences, Engineering, Life Sciences, or a related field.
• Minimum 5-7 years of project management experience in the pharmaceutical industry.
• Strong knowledge of validation (process, cleaning, equipment, and computer systems validation).
• Experience with change control management systems and regulatory compliance.
• Familiarity with GMP, FDA, EU regulations, and ICH guidelines.
• Proficiency in project management tools (MS Project, Jira, Smartsheet, etc.).