Orion Innovation is a premier, award-winning, global business and technology services firm. Orion delivers game-changing business transformation and product development rooted in digital strategy, experience design, and engineering, with a unique combination of agility, scale, and maturity. We work with a wide range of clients across many industries including financial services, professional services, telecommunications and media, consumer products, automotive, industrial automation, professional sports and entertainment, life sciences, ecommerce, and education.
Top Skills:
• 7+ years of experience in project management, commercial operations, or launch operations within the pharmaceutical or biotech industry
• Proven track record managing complex, multi-workstream programs in a senior capacity
• Demonstrated ability to adapt priorities fluidly based on evolving business needs across a broad operational scope
• Strong experience building and maintaining PM documentation
• Experience with metrics and data reporting, including presenting insights to senior stakeholders
• Excellent written and verbal communication skills; confident facilitating cross-functional meetings and driving accountability
• Exceptional collaboration skills; this role requires daily partnership with a wide range of internal teams, IT partners, and external vendors; the ability to build strong working relationships across all levels is essential
• Full training on Lx systems and tools will be provided; a willingness and ability to learn new platforms quickly is required
Summary:
This role will focus on the Computer System Validation (CSV) activities for enterprise GxP systems, specifically for a critical set of projects in the Cell Therapy functional area. This role will be supporting validation leads to help ensure the required deliverables and testing are complete according to the client CSV SOP. Effective communication is key across a multi-functional team consisting of Business, IT, and Quality personnel. Experience with current digital validation tools is required, use of AI as an accelerator is a plus. Overall a solid CSV background and having a strong work ethic in an aggressive project setting will be key to being successful in this role.
Responsibilities:
- Support creation, review, and approval of all CSV deliverables for custom in-house solutions.
- Maintain close communication with stakeholders and team members to keep apprised of CSV needs, interpretation of requirements, impacts on compliance of an application, project status, and other relevant issues
- Ability to create documents to an existing document standard
- Obtain and respond to review by Business, IT, and Quality stakeholders