Vertex is looking to solve technical operations problems in packaging and process operations, working with internal and external cross-functional teams in a fast-paced environment.
Requirements
- Good knowledge of cGMP’s and associated CMC regulatory considerations in a pharmaceutical environment
- Fundamental understanding and application of validation processes (IQ/OQ/PQ/PV)
- Experience or certification in LEAN and/or Six Sigma practices is a plus
- Knowledge of packaging technology, sustainability, and industry activity
- Ability to work with multiple stakeholders including Pharmaceutical Sciences, Regulatory Affairs, Project Management, Supply Chain, Quality, and Marketing
- Ability to author and review packaging qualification and validation documents
- Understanding of pharmaceutical packaging processes and equipment
Responsibilities
- Maintains effective relationships between Vertex and key suppliers of materials, technology, and manufacturing resources
- Provides technical support on packaging processes to Package Engineering and cross functional teams
- Author and/or review validation and change control documents such as master batch records, protocols, reports and change requests
- Supports packaging projects and process improvement efforts, validations, equipment installation, IQ/OQ/PQ protocol development and execution
- Participates on cross-functional CMC sub-teams
- Evaluates process performance to identify and lead continuous improvement activities for commercial products
- Supports resolution of quality investigations
Other
- Ability to travel domestic and international (Approximately 25%)
- Bachelor's degree in Packaging, Chemical, Mechanical, Material or Industrial Engineering, or a related field
- Typically requires 4 years of experience or the equivalent combination of education and experience
- Excellent project management experience
- Solid communication, analytical, problem solving and collaboration skills to exchange complex information with others in complex situations
- Demonstrated ability to manage multiple projects concurrently, and flexibility to accommodate changes in responsibilities or project priorities
