What are the responsibilities and job description for the Compliance and Regulatory Manager position at Arcadis?
About the Job
We are seeking a highly skilled Validation Engineer to join our team and contribute to ensuring compliance with industry standards and regulatory requirements for our products and processes.
Key Responsibilities
- Develop and optimize autoclave sterilization cycles to ensure product sterility and compliance with regulatory standards.
- Conduct validation studies, including cycle development, load configuration, and validation execution.
- Analyze and interpret data to confirm process reliability and effectiveness.
Additional Responsibilities
- Perform risk assessments related to environmental monitoring to identify critical control points.
- Generate and execute Performance Qualification (PQ) protocols for Environmental Monitoring systems to ensure compliance with regulatory guidelines.
- Collaborate with cross-functional teams for EM validation activities (excluding sampling tasks).
Requirements and Qualifications
- Bachelor's degree in Engineering (e.g., Mechanical, Chemical, Biomedical, or related field) or equivalent experience in validation.
- 3 years of experience in validation activities within the pharmaceutical, biotechnology, or medical device industry.
- Strong knowledge of regulatory requirements (e.g., FDA, EMA, ISO 13485, GMP).
- Experience with autoclave sterilization processes and utility systems validation.
- Proficiency in risk assessments, protocol generation, and execution.
- Excellent attention to detail, data analysis, and technical writing skills.
- Ability to work collaboratively in cross-functional teams.
- Ability to provide legal US work authorization documents required.
