Quality Assurance Validation Engineer

Job Description

Arcadis is seeking a QAV Engineer in Boston, MA to provide QA oversight of commissioning, qualification, and validation activities.

Requirements

• Bachelor’s degree or equivalent in Engineering, Science, or related discipline
• 3+ years of experience working in a GMP manufacturing/ facilities role
• Experience in pharmaceutical or biopharmaceutical/biotechnology cGxP environment
• Knowledge of Industry guidelines (ISPE, PDA) US and international regulations (FDA, cGMP, ICH, ISO, EMA) for validation of GMP facilities
• Strong verbal, written, and interpersonal communication skills

Responsibilities

• Provide QA oversight of commissioning, qualification, and validation activities
• Support continuous quality system improvements
• Participate in cross functional meetings for planning and discussing changes to be commissioned, qualified, validated equipment/facilities/utilities
• Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements
• Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence

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.