Cleaning Validation Specialist

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.

Position Summary:

Arcadis is seeking an experienced Cleaning Validation Specialist to support ongoing manufacturing and validation project. Reporting to the Validation Manager, this person will execute cleaning validation activities, author and execute protocols, evaluate acceptance criteria, and confirm that equipment-cleaning processes meet regulatory and quality requirements in a GMP biopharmaceutical manufacturing environment. The ideal candidate brings hands‑on cleaning validation experience, strong knowledge of Total Organic Carbon (TOC) acceptance-criteria calculations, and experience with chromatography skids, tangential flow filtration (TFF) systems, and stainless‑steel processing vessels.

Key Responsibilities:

• Execute cleaning validation protocols in support of GMP manufacturing operations.
• Support the cleaning validation lifecycle, including protocol development and execution, data collection and review, and final report generation.
• Develop, calculate, and assess cleaning acceptance criteria using Maximum Allowable Carryover (MACO), Acceptable Daily Exposure (ADE), Permitted Daily Exposure (PDE), and batch-size calculations.
• Perform and review Total Organic Carbon (TOC) calculations and acceptance‑criteria assessments.
• Support validation of Cytiva TFF systems, chromatography process skids, and 3,000‑liter stainless‑steel manufacturing vessels.
• Evaluate Clean‑in‑Place (CIP) processes and cleaning agents, including sodium hydroxide (NaOH), Water for Injection (WFI), CIP 100, and CIP 200.
• Collaborate with Validation, Manufacturing, Quality Assurance, and Engineering teams to coordinate execution and resolve technical issues.
• Support investigations, deviations, root‑cause analyses, and protocol‑related documentation as required.
• Ensure all activities comply with GMP regulations, internal procedures, approved protocols, and industry best practices.

Required Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, Biotechnology, Chemistry, or a related field.
• At least three years of cleaning validation experience in pharmaceutical, biotechnology, biologics, or a comparable GMP manufacturing environment.
• Hands‑on experience authoring and executing cleaning validation protocols and preparing validation documentation.
• Demonstrated ability to calculate and establish TOC acceptance criteria and cleaning limits using MACO, ADE, PDE, and batch‑size methodologies.
• Strong understanding of cleaning validation regulatory expectations and GMP requirements.
• Experience supporting deviations, root‑cause investigations, and technical report writing.
• Ability to work fully onsite in Milford, Massachusetts, Monday through Friday during the day shift.

Preferred Qualifications:

• Experience with Cytiva manufacturing equipment, chromatography skids, and TFF systems.
• Knowledge of CIP processes and cleaning agents such as NaOH, WFI, CIP 100, and CIP 200.
• Prior biologics manufacturing experience.

Must‑Have

Skills:

Cleaning validation; TOC testing and calculations; MACO, ADE, and PDE assessments; protocol execution; GMP compliance; validation documentation; root‑cause investigation; and technical writing.

This long‑term, fully onsite opportunity supports a leading biologics manufacturing organization and is ideal for a hands‑on cleaning validation professional who enjoys working directly on the manufacturing floor.

Why Arcadis?

We…