PCI Pharma Services · 1 week ago
Quality Engineer -Sustaining Engineering (SE)
Rockford, IL
Full-time
Onsite
Mid Level
$97K/yr - $116K/yr
3+ years expPCI Pharma Services is a company focused on life-changing therapies and global impact. They are seeking a Quality Engineer to be responsible for planning, developing, implementing, and monitoring the equipment and process validation strategy for their Advanced Drug Delivery business.
BiotechnologyHealth CareLife ScienceMedical DevicePackaging ServicesPharmaceutical
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
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 timeframes 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 development, manufacturing, and procurement teams for high priority product-program initiatives
Attention to detail and self-motivation to deliver work to the highest standards
Multi-tasking, 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 Manager/Supervisor within device assembly and packaging operations. May assist in the areas of NPI as needed
Support the recruitment, management, coaching, and development of quality engineers to achieve excellence and efficiency when programs are scaled
Knowledge of and adherence to all PCI, cGMP, GCP, GAMP, 21CFR, 21CFR Part 11 and Annex 11 policies, procedures, rules, and requirements
Qualification
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
Benefits
Paid time off
Health insurance coverage (including dental and vision)
Flexible spending account
401(k) plan
Company
PCI Pharma Services
PCI Pharma Services is a provider of outsourced services to the global pharmaceutical market.
5001-10000 employees
H1B Sponsorship
PCI Pharma Services has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
2020 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2025-07-14Series Unknown
2020-08-24Acquired
2014-08-10Seed
Leadership Team
Gil Valadez
Chief Operating Officer
Recent News
2025-07-22
Company data provided by crunchbase