West Pharma Validation Manager CCI 

United States, Pennsylvania, West Whiteland Township 

228852583

In this role, you will be responsible for being the subject matter expert in container closure integrity techniques and methodology of drug packaging and drug delivery systems. This role is responsible for independently gathering and understanding industry knowledge and implementing new technologies, techniques, and strategies as they apply to drug packaging and combination product testing to effectively support the organization in identifying and growing future analytical expertise and capabilities. This role will also support in ensuring compliance to established and legacy programs withing the container closure integrity team.

• Conform with and abide by all regulations, policies, work procedures, instruction, and all safety rules
• Must have an in-depth understanding of container systems such as vials, cartridges, prefilled syringes, autoinjectors, on-body delivery systems and other combination products
• Must have an in-depth understanding of testing standards (USP, EP, ISO, ASTM etc.), testing techniques, and validation requirements for container and delivery systems
• Gather industry and current technology knowledge as it applies to the field of container closure integrity testing to effectively support the organization in identifying and growing future analytical expertise. Must be able to communicate, present and educate the team on the testing and technology related to these spaces
• Understand industry regulations and put together a plan to bring the necessary capability and technology into the West Services and Solutions organization to support business
• Act as the technical owner of the container closure integrity testing area. Identifying means of bridging gaps to support customer and product needs, and collaboratively work with other West functions
• Proactively identify opportunities and design/develop studies or techniques regarding container closure integrity testing of container systems, combination products and devices
• Devise solutions to close or bridge any compliance gaps through regulatory change to existing programs
• Identify fixturing or tooling needed to support laboratory operations to meet customer needs
• Build relationships and network with key technical and opinion leaders in the industry and with West customers around container closure integrity testing
• Establish relationships with instrument manufacturers to build future analytical capabilities or to outsource testing when West does not have the capability in-house
• Develop and own business cases to purchase new analytical capabilities and present to management
• Be responsible for implementing new technologies and for training the lab team on their utilization
• Author procedures and work instructions for techniques, processes, and verification/validation strategy related to performance testing
• Other duties as assigned, based on business needs

• Minimum of BS in an Analytical sciences, technical discipline or equivalent experience

• Minimum of 8 years of experience with at least 5 years relating to container closure integrity testing and methodology of Delivery Systems, Medical Devices or Combination Products and pharmaceutical testing experience
• Familiarity with CCI techniques and testing equipment
• Detailed understanding of USP 71, USP 381, USP 382, and USP 1207 requirements or guidance

• Graduate degree in a technical discipline
• Possess excellent communication and presentation skills
• Be proficient in Microsoft Office
• Be aware of all relevant SOPs, as per Company policy, as they are related to the position covered by this Job Description
• Ability to comply with the company’s safety and quality policies at all times

• Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read & write, speak in front of groups, express & exchange ideas, understand direction and adhere to procedures
• Organizational skills will enable planning, prioritization & achievement of goals especially of importance for the successful execution of related activities
• Position operates in a professional office environment. May stand or sit for extended periods of time
• Read and interpret data, information and documents
• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task, work under time constraints, problem solve, and prioritize
• Ability to make independent and sound judgments
• Independently observe and interpret situations, analyze and solve problems#LI-HYBRID