Quality Engineer – Sustaining Engineering
PCI Pharma Services
full-time
Posted on:
Location Type: Office
Location: Linden • Illinois • 🇺🇸 United States
Visit company websiteSalary
💰 $97,280 - $115,520 per year
Job Level
Mid-LevelSenior
Tech Stack
ERP
About the role
- Plan, develop, implement and monitor the equipment and process validation strategy for PCI’s Advanced Drug Delivery business
- Partner with internal team members to ensure successful design/tech transfer with NPI by supporting or driving validation processes with appropriate risk management leadership
- Responsible for supporting all phases process qualification, ensuring product production according to established control plan, design and product specifications
- Drive continual improvement by implementing validation strategies, conducting tests, and analyzing data to confirm compliance and functionality
- Interact and collaborate with internal team members, customers, suppliers, and contract service providers as needed
- Develop and implement product and process workflows to ensure best engineering practices
Requirements
- College or Trade Degree required (engineering degree or related scientific degree preferred)
- 3+ years of experience in an FDA regulated industry with strong preference to medical device or combination products
- 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
- 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
- Critical thinking skills along with a strong collaborative approach
- 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)
- a flexible spending account
- 401(k) plan
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
process validationequipment validationprocess qualificationvalidation strategiesdata analysistechnical writingroot cause analysisTest Method validationSterilization processes
Soft skills
organizational skillstime managementmulti-taskingcritical thinkingcollaboration
Certifications
Lean Six Sigma CertificationASQ Certified Quality Engineer (CQE)