Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Summary of Objective: The Quality Engineer (QE) is a key, customer-facing role that will be responsible for planning, developing, implementing and monitoring the equipment and process validation strategy for PCI’s Advanced Drug Delivery business. The QE will partner with other internal team members to ensure a successful design/tech transfer with NPI by directly supporting or driving validation processes with appropriate risk management leadership. As the new product is fully scaled into commercial operations, the QE will be responsible or support all phases process qualification, ensuring the product is produced according to the established control plan, design and product specifications, and driving continual improvement by implementing validation strategies, conducting tests, and analyzing data to confirm compliance and functionality. The QVE will interact and collaborate with internal team members, customers, suppliers, and contract service providers as needed. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.