Biopharma 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 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