Quality Engineer -Sustaining Engineering; SE

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.

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 QE will interact and collaborate with internal team members, customers, suppliers, and contract service providers as needed.

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.

• Drive and support new customer programs throughout the development lifecycle and deliver on the 'One PCI' customer experience and program management
• Interact with clients on an as-needed basis to support project milestones, scope changes and business development opportunities.
• Develop and implement product and process workflows to ensure best engineering practices within the quality and engineering teams.
• Prepares and executes validation protocols (IOQ, OQ/PQ) and validation standards, validation statements, reports, summaries, and master validation plan for new customer/product/system project launch and maintains existing validated processes and coordinating internal and customer approvals, as needed.
• Ensures validation documentation completion, accuracy, and closure, including organizing and coordinating multiple approvals as required.
• Development of sampling plans for OQ/PQ activities (includes Serialization activities).
• Trend manufacturing data and contract service providers results for ongoing process verification.
• Reviews and interprets standards, procedures, and specifications for dissemination relative to validation protocols.
• Review and/or approve User Requirement Specifications, Functional Specifications, and Engineering Study Protocols Review and possibly assist in Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) to qualify equipment.
• Harmonization/streamlining of validation activities
• Assistance with development of Master Batch Records, work instructions and associated manufacturing and packaging documentation.
• Drive root cause analysis of deviations.
• Support project teams through the selection of correct design / manufacturing concepts and fundamental technology to ensure successful project outcomes.
• Develop validation work standards and packages as part of project acquisition process and following subsequent project delivery stages, to successfully deliver projects within scope, with quality, and within allocated time frames and budget.
• Interpret product requirements and design and develop concepts, components, assemblies, and products in compliance with applicable quality system procedures, industry, and business standards.
• Effectively communicates project goals and progress to Supervisor / Manager. Investigates validation deviations, documenting in formal reports, and assuring resolution of corrective action to complete the project.
• Coordinate validation efforts with mechanics, operators, and engineering
• Attends conference calls and meetings

• Collaborate with the engineering, commercial operations, procurement and ancillary groups and wider…