Cleaning/Process Validation Engineer - Arcadis : Job Details

About The Job

Arcadis is the world's leading company delivering sustainable design, engineering, and consultancy solutions for natural and built assets.

We are more than 36,000 people, in over 70 countries, dedicated to improving quality of life. Everyone has an important role to play. With the power of many curious minds, together we can solve the world's most complex challenges and deliver more impact together.

Role description:

Arcadis is seeking a Cleaning/Process Validation Engineer who is responsible for Process validation and Cleaning validation activities related to the product manufacturing on the site.

Role accountabilities:

• Demonstrate a solid understanding, knowledge, skill set, and experience in Cleaning Fundamentals (i.e., Regulatory Issues &Cleaning Validation Requirements; Cleaning Principles, Cleaning Strategies; Risk Assessments, Analytical/Sampling Methods, etc.)
• Provide cross-functional leadership and quality/compliance expertise in cGMP US, EU, and other regulatory best practices
• Develop, Execute, document process validation protocols (IQOQPQ) for manufacturing processes, ensuring compliance with regulatory requirements and company standards
• Analyze process data to establish critical process parameters (CPPs) and critical quality attributes (CQAs) for robust and repeatable manufacturing processes.
• Apply best industry practices for various Cleaning Methods (i.e., Automated [Clean IN Place, CIP]; Semi-Automated [Clean Out Place, COP]; Manual Cleaning)
• Design, plan and execute experiments (i.e., cleaning process design/development) to demonstrate robustness, optimize processes, and efficiency of cleaning processes with the goal of product quality and safety
• Generate and modify cleaning procedures/work instructions for new products / new process and/or existing manufacturing equipment
• Lead and participate in the initial cleaning validation activities' deliverables (i.e., scheduling, assessment; training; documentation; execution; issue resolution; reporting, etc.)
• When required, investigate and conduct troubleshooting/root cause analysis of cleaning-related incidents, deviations, and cleaning out of specification results for non-validated or under-development cleaning procedures
• Audit current cleaning processes and ensure compliance with cGMP, Site/Global quality policies and current industry standards
• Perform routine verification studies (continued process verification, CPV)
• Maintain the validated status of cleaning processes
• Provide technical support and expertise related to the cleaning process, critical quality attributes related to the output of the cleaning as well as critical cleaning agent parameters, process equipment assessment and analytical methods &recovery study)
• Conduct Cleaning Verification deliverables and activities (as applicable) to
• Demonstrate the effectiveness of the cleaning process using a single cleaning and cleanliness testing exercise as part of the cleaning process assessment
• Generate validation protocols, risk assessments and supportive developmental studies for cleaning processes
• Conduct a risk-based approach throughout the cleaning process validation lifecycle from process design, throughout cleaning process qualification, and into continued cleaning process verification (i.e., grouping/worst case representatives; physical/chemical properties of soil &product residue; equipment design/equipment train; cleaning agents; analytical methods, etc.)
• Establish equipment hold times (i.e., Dirty Hold Time [DHT] and Clean Hold Time [CHT]) throughout the set of cleaning process qualification activities
• Where applicable, generate a Position Paper to provide equivalency in the cleaning process/procedure for similar and/or identical process equipment cleaning
• Generate reports for cleaning process validation, and technical reports for specific projects
• Participate in project teams, working groups and task forces (local and or global)
• Responsible for scientific and technical aspects of assigned projects and activities
• Proficient knowledge of cleaning validation, continuous process improvement and troubleshooting processes
• Interact with cross-functional teams in Manufacturing Science; Operations/Production; Engineering; Facility; Quality (QC; QA) to support process development, process improvement and validation
• Other duties as assigned

Qualifications & Experience:

Minimum education - Bachelor's or Master's degree in Life Sciences, Pharmacy, or Chemistry; Biology or related Engineering discipline (Chemical Engineering).

Minimum of 5-7 years of professional hands-on and direct cleaning validation experience (CIP; COP; Manual Cleaning) in pharmaceutical/biotech industries.

Broad knowledge of regulatory compliance and its relation to cleaning of product contact equipment in the biopharmaceutical manufacturing environment.

Proficient knowledge of cleaning validation, continuous process improvement and troubleshooting processes.

Excellence in writing, reviewing, and executing cleaning verification/validation protocols; design of experiments (DOE); risk assessment and technical reports.

Working experience in adopting ASTM E2500 standards.

Current member of ISPE in Cleaning Validation.

Expertise and experience with contract development manufacturing and sterile/aseptic operations.

General knowledge of process flows and personnel flows in the biopharma manufacturing environment

Ability to provide legal US work authorization documents required. Will consider US domestic travelers and relocation.

Why Arcadis?

We can only achieve our goals when everyone is empowered to be their best. We believe everyone's contribution matters. It's why we are pioneering a skills-based approach, where you can harness your unique experience and expertise to carve your career path and maximize the impact we can make together.

You'll do meaningful work, and no matter what role, you'll be helping to deliver sustainable solutions for a more prosperous planet. Make your mark, on your career, your colleagues, your clients, your life and the world around you.

Together, we can create a lasting legacy.

Join Arcadis. Create a Legacy.

Our Commitment to Equality, Diversity, Inclusion & Belonging

We want you to be able to bring your best self to work every day which is why we take equality and inclusion seriously and hold ourselves to account for our actions. Our ambition is to be an employer of choice and provide a great place to work for all our people. We are an equal opportunity and affirmative action employer. Women, minorities, people with disabilities and veterans are strongly encouraged to apply. We are dedicated to a policy of non-discrimination in employment on any basis including race, creed, color, religion, national origin, sex, age, disability, marital status, sexual orientation, gender identity, citizenship status, disability, veteran status, or any other basis prohibited by law.

Arcadis offers benefits for full time and part time positions. These benefits include medical, dental, and vision, EAP, 401K, STD, LTD, AD&D, life insurance, paid parental leave, reward & recognition program and optional benefits including wellbeing benefits, adoption assistance and tuition reimbursement. We offer nine paid holidays and 15 days PTO that accrue per year. Salaries will vary and are based on several factors, such as experience, education, budget, internal equity, project and location.