Quality Engineer – Sustaining Engineer

PCI Pharma Services; Philadelphia (Philadelphia County); On-site; USD 85,000 - 120,000; Full time

Job summary

PCI Pharma Services in Philadelphia is seeking a Quality Engineer – Sustaining Engineer to lead quality lifecycle activities as products transfer from NPI to commercial operations. You will drive design/tech transfer, ensure products meet control plans and specifications, and partner with site leadership to reduce variation in manufacturing and packaging processes.

You will perform root-cause analysis, CAPA, and data-driven improvements, support validation and qualification activities, and

Qualifications

• Bachelor's degree or trade equivalent; minimum 3 years in an FDA-regulated industry (medical device/biologics preferred).
• Proficiency with MS Office; experience with ERP/eQMS tools and data presentation.
• Strong root-cause analysis and problem-solving skills; ability to drive CAPA and continuous improvement.

Responsibilities

• Lead quality lifecycle activities for sustaining engineering and product transfers from NPI to commercial operations.
• Disposition non-conforming product; drive CAPA and root-cause investigations.
• Support validation/qualification activities and provide documentation (MRA, Control Plans, inspection plans).
• Collaborate with clients, suppliers, and internal teams to ensure compliant, high-quality manufacturing and packaging.

Skills

Quality Engineering

RCA analysis

Data analysis

MS Office

eQMS systems

ERP systems

Analytical thinking

Communication skills

Education

Engineering degree or related scientific degree

Tools

ERP systems

eQMS systems

Job description

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.

Position Title: Quality Engineer - Sustaining Engineer

Location: 3001 Red Lion Road, Philadelphia, PA 19114

Shift: 1st Shift

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 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 quality of incoming materials (lot to lot variation) in order to ensure reduction of variation in the product manufacturing process. The QE will be responsible for dispositioning non-conforming product and driving root cause 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 for validation, qualification, and periodic change assessment activities as required.

Essential Duties and Responsibilities:

Technical (Product and Process)

• 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 (includes 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 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, 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 modelling, DFM, and process validation/qualification.
  • Employ data driven tools and methodologies to implement structured and timely problem.
  • Development and/or review of technical specifications

Supplier Quality

• 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, in order to drive appropriate and timely improvement with key suppliers.

Leadership

• 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.

Other - General

• Attendance to work is an essential function of this position.
• Performs other duties as assigned by Manager/Supervisor within commercial operations. May assist in the areas of NPI as needed.
• Support the recruitment, coaching, and development of quality engineers to achieve excellence and efficiency when programs are scaled.

Qualifications:

Required

• College or Trade Degree required (engineering degree or related scientific degree preferred). Must have a minimum of at least three years of experience in an FDA regulated industry with strong preference to medical device 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 solving.

Preferred

• Lean Six Sigma Certification, ASQ Certified Quality Engineer (CQE), or similar certifications are highly desirable.
• Possesses 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 is required
• Technical knowledge and experience around Test Method validation, Medical Devices, and Sterilization processes is preferred.

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

Equal 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 highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.