GMP CQV Engineer: Validation, Startups & Compliance

Arcadis; Boston (MA); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401K

Life insurance

Parental leave

Wellbeing benefits

Job summary

Arcadis is seeking a Validation Engineer to support commissioning, qualification, validation, requalification, and lifecycle management activities within a GMP-regulated pharmaceutical environment. You will develop and execute validation documentation and support capital projects, ensuring compliance with regulatory requirements.

The role requires coordinating cross-functional teams across Manufacturing, Facilities, QA, and Engineering, authoring IQ/OQ/PQ, FAT/SAT, and maintaining validated

Qualifications

• Bachelor's degree in a relevant engineering discipline.
• Experience in GMP-regulated pharma/biotech environments.
• Experience authoring IQ/OQ/PQ, FAT and SAT protocols.
• Knowledge of GMP, GDP, CQV principles and lifecycle.
• Strong technical writing and documentation skills.
• Ability to read engineering drawings and P&IDs.
• Experience with cross-functional teams.

Responsibilities

• Execute CQV activities for equipment, labs, facilities, utilities.
• Create and review validation plans, RTMs, and reports.
• Coordinate validation with Manufacturing, Facilities, QA, and Engineering.
• Manage change controls, deviations, CAPAs, and non-conformance resolution.
• Support audits and inspection readiness.
• Assist with startup, commissioning of capital projects.

Skills

Technical writing

CQV knowledge

Cross-functional collaboration

GMP understanding

Education

Bachelor's degree in Engineering or related field

Job description

Arcadis is seeking a Validation Engineer to support commissioning, qualification, validation, requalification, and lifecycle management activities within a GMP-regulated pharmaceutical environment. You will develop and execute validation documentation and support capital projects, ensuring compliance with regulatory requirements.

The role requires coordinating cross-functional teams across Manufacturing, Facilities, QA, and Engineering, authoring IQ/OQ/PQ, FAT/SAT, and maintaining validated