Cleaning Validation Specialist

Arcadis; Boston (MA); On-site; USD 95,000 - 125,000; Full time

Job summary

Arcadis is seeking an experienced Cleaning Validation Specialist to support ongoing GMP manufacturing and validation projects in Milford, MA. The role focuses on executing validation activities, authoring protocols, and confirming that cleaning processes meet regulatory and quality requirements in a biopharma setting.

The ideal candidate will have hands‑on TOC calculations, MACO/ADE/PDE methodologies, and experience with Cytiva TFF systems, chromatography skids, and large stainless‑steel

Qualifications

• Bachelor's degree in engineering, life sciences, biotechnology, chemistry, or related field.
• At least three years of cleaning validation experience in GMP pharma/manufacturing.
• Hands‑on experience authoring and executing cleaning validation protocols and preparing validation documentation.
• Ability to calculate TOC acceptance criteria and cleaning limits using MACO, ADE, PDE, and batch‑size methods.
• Strong understanding of cleaning validation regulatory expectations and GMP requirements.
• Experience supporting deviations, root‑cause investigations, and technical report writing.
• Willingness to work fully onsite in Milford, MA, Monday–Friday day shift.

Responsibilities

• Execute cleaning validation protocols in support of GMP manufacturing operations.
• Develop, document, and review validation data and final reports.
• Calculate MACO/ADE/PDE values and batch-size based acceptance criteria.
• Perform TOC testing and acceptance‑criteria assessments.
• Support validation of Cytiva TFF systems, chromatography skids, and 3,000‑liter vessels.
• Evaluate CIP processes and reagents including NaOH, WFI, CIP 100 and CIP 200.
• Collaborate with Validation, Manufacturing, QA, and Engineering to resolve issues.
• Assist investigations, deviations, and protocol-related documentation as required.

Skills

Cleaning validation

TOC testing

MACO/ADE/PDE calculations

Protocol execution

GMP compliance

Technical writing

Education

Bachelor's degree in Engineering, Life Sciences, Biotechnology, Chemistry, or related field

Tools

Cytiva equipment

Chromatography skids

TFF systems

Stainless‑steel manufacturing vessels

NaOH, WFI CIP

Job description

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 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.