Reference #: JR113766
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 - Sustaining Engineering (SE) is a key, customer-facing role that will be responsible for or support all phases of the product quality lifecycle of the customer program as the product transfers from NPI into commercial operations. The QE (SE) will ensure a successful design/tech transfer with NPI by directly supporting or driving the tech and design transfer processes with appropriate risk management leadership. As the new product is fully scaled into commercial operations, the QE (SE) will be responsible for or support all phases of quality operations, ensuring the product is produced according to the established control plan, design, and product specifications and driving continual improvement to ensure ongoing standardization, simplification, and optimization of the product manufacturing-assembly and final packaging processes. As a key part of the Quality Operations Team, the QE (SE) will work directly with the site leadership and operational teams to assess, analyze, and trend the quality of incoming materials (lot to lot variation) to ensure the reduction of variation in the product manufacturing process. The QE will be responsible for dispositioning non-conforming products and driving root causes during investigations, with appropriate CAPA to prevent reoccurrence. The QE will interact and collaborate with internal team members, customers, suppliers, and contract service providers as needed and assist Validation Engineers with validation, qualification, and periodic change assessment activities as required.Responsibilities
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 for DFA/DFM (DFMA) into sustainable engineering and commercial operations
Test method transfer or method validation activities
Development of sampling plans for OQ/PQ activities (including Serialization and Sterilization activities)
Trend manufacturing data and contract service providers' results
Development of validation/re-qualification protocols
Development of Master Batch Records, work instructions, and associated manufacturing and packaging documentation
Drive root cause analysis of deviations/complaints
Support project teams through the selection of correct design/manufacturing concepts and fundamental technology to ensure successful project outcomes
Develop work standards and packages as part of the project acquisition process and following subsequent project delivery stages to successfully deliver projects within scope, with quality, and within allocated timeframes and budget
Identify opportunities and develop recommendations to improve product and process design
Interpret product requirements and design and develop concepts, components, assemblies, and products in compliance with applicable quality system procedures and industry and business standards
Supports the generation of documentation such as Measurement System Analysis (MSA), Control Plans, Process Flow Maps, Inspection plans and techniques, GR&R & test requirements
Maintain QE process discipline to achieve project deliverables, including but not limited to supporting manufacturing strategy, capability analysis, FMEA, tooling selection, risk management, supporting cost modeling, DFM, and process validation/qualification
Employ data-driven tools and methodologi s to implement structured and timely problems
Development and/or review of technical specifications
Participate in External Audits of Suppliers/Contract Service Providers
Manage internal and external suppliers required to support product design tasks
Track and trend raw material and key components to measure variation and part quality over time to drive appropriate and timely improvement with key suppliers
Collaborate with the engineering, commercial operations, procurement, and ancillary groups and wider development, manufacturing, and procurement teams for high-priority product-program initiatives
Attention to detail and self-motivation to deliver work to the highest standards
Multitasking, planning work, scheduling tasks, coordinating activities, and managing time efficiently
Timely problem-solving using data-driven tools and methods
Presentation of quality standards, process flows, inspection plans, and/or issues both internally to stakeholders and externally to clients with confidence and accuracy
Attendance to work is an essential function of this position
Performs other duties as assigned by the Manager/Supervisor within commercial operations
Support the recruitment, coaching, and development of quality engineers to achieve excellence and efficiency when programs are scaledRequirements
College or Trade Degree required (engineering degree or related scientific degree preferred)
Minimum of at least three years of experience in an FDA-regulated industry with a strong preference for medical devices or combination products
Demonstrated proficiency with personal computers, business software (e.g., MS Office), and technical software (ERP and eQMS systems)
Ability to create, use, and interpret scientific tables, charts, and graphs
Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs
Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs
Analytical ability to drive effective Root Cause Analysis (RCA) and critical thinking for complex problem-solvingNice-to-haves
Lean Six Sigma Certification, ASQ Certified Quality Engineer (CQE), or similar certifications are highly desirable
Excellent organizational, time management, and multi-tasking skills to meet commitments and deadlines
Prior experience in technical writing and utilizing root cause analysis tools is required
Critical thinking skills, along with a strong collaborative approach, are required
Technical knowledge and experience around Test Method validation, Medical Devices, and Sterilization processes are preferredBenefits
Paid time off
Health insurance coverage (including dental and vision)
Flexible spending account
401(k)
#LI-KH1Join us and be part of building the bridge between life changing therapies and patients. Let's talk futureEqual Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the hi