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Quality Engineer - Sustaining Engineering

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PCI Pharma Services

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Location:
United States , Rockford

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Category:
Manufacturing

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Contract Type:
Not provided

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Salary:

97280.00 - 115520.00 USD / Year
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Job Description:

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.

Job Responsibility:

  • Drive and support new customer programs throughout the development lifecycle
  • 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
  • Prepares and executes validation protocols (IOQ, OQ/PQ) and validation standards, validation statements, reports, summaries, and master validation plan
  • Ensures validation documentation completion, accuracy, and closure
  • Development of sampling plans for OQ/PQ activities
  • Trend manufacturing data and contract service providers results for ongoing process verification
  • Reviews and interprets standards, procedures, and specifications
  • 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)
  • 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
  • Develop validation work standards and packages
  • Interpret product requirements and design and develop concepts, components, assemblies, and products
  • Effectively communicates project goals and progress to Supervisor / Manager
  • Investigates validation deviations, documenting in formal reports
  • Coordinate validation efforts with mechanics, operators, and engineering
  • Attends conference calls and meetings
  • Collaborate with the engineering, commercial operations, procurement and ancillary groups
  • Support the recruitment, management, coaching, and development of quality engineers
  • Knowledge of and adherence to all PCI, cGMP, GCP, GAMP, 21CFR, 21CFR Part 11 and Annex 11 policies, procedures, rules, and requirements

Requirements:

  • 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 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
  • 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

Nice to have:

  • 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
What we offer:
  • Eligibility for an 5% MBP
  • Paid time off
  • Health insurance coverage (including dental and vision)
  • Flexible spending account
  • 401(k) plan

Additional Information:

Job Posted:
February 20, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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