Senior Quality Engineer
Arcadis Triangle, NC Full-time 3/24/2026
Undergraduate with 5+ Years of Experience
Approval 98.4%•Total filings 122•New hires 57•
✓ Established Sponsor
•FY 2025Job Description
Arcadis is seeking a Senior Quality Engineer to support GMP Manufacturing Operations. The role involves providing Quality Engineering support, consulting on quality systems, and ensuring compliance with GMP standards in a pharmaceutical environment.
Requirements
- Bachelor’s Degree in relevant disciplines in life sciences.
- 5+ years of QE/QA experience in a pharmaceutical or therapeutic environment.
- Demonstrates working knowledge of current Good Manufacturing Practices (GMPs).
- Strong understanding of applicable regulatory requirements and guidance documents (21 CFR, USP, EP, ICH).
- Ability to thrive in a fast-paced dynamic environment with the ability to maintain objectivity and autonomy regarding quality and compliance.
- Demonstrated knowledge of quality management systems, processes, and procedures.
- Strong interpersonal and communications skills; written and oral.
- Outstanding planning, organization and multitasking skills.
- Must be a team player and exhibit a willingness to meet project timelines.
- Extremely high degree of attention to detail.
- Ability to provide legal US work authorization documents required.
Responsibilities
- Provide Quality Engineering support for the GMP Manufacturing Operations Workstream.
- Provide Quality Engineering consulting support on the development and execution of the FUME and Manufacturing Quality System for GMP manufacturing.
- Provide Quality Engineering consulting support on the development and execution of Quality Engineering procedures to support GMP Manufacturing Operations.
- Review and approve FUME and Manufacturing documents, as required (e.g., validation, maintenance, calibration, operational procedures, etc.).
- Provide onsite participation in walkthroughs, tours, or workshops at the NC Facility.
- Provide any additional ad hoc Quality Engineering support for GMP Manufacturing readiness.
- QC Lab Buildout: AIV validation, Changeover Support, Cleaning Validation, CCS (Risk Assessments), Data Integrity (IT Systems, AI Integration), Raw Materials and GEP Policy Development and Implementation.
- Other duties as assigned.
Benefits
- Employees at Arcadis are often offered a supportive, inclusive culture with internal mobility, extensive learning and development resources, and the flexibility to choose benefits that fit their needs (varying by country). Many roles also emphasize purpose and community—through sustainability initiatives, charitable programs like Shelter, and regular social and volunteer events—so people can grow their careers while making a positive impact.
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