Pharmaceutical Validation Scientist – Cleaning Processes

no C2C please

Job Description:

We’re looking for a skilled Cleaning Validation Engineer to join our pharmaceutical manufacturing team. In this role, you’ll ensure our cleaning processes meet strict regulatory standards (FDA, EMA, WHO) while driving efficiency and quality. If you’re detail-oriented, collaborative, and ready to make an impact, we want to hear from you!

Key Responsibilities:

• Create and manage cleaning validation documentation, including master plans, protocols, and reports.
• Develop and execute IQ/OQ/PQ protocols for equipment, CIP/SIP systems, and utilities.
• Conduct risk assessments, gap analyses, and residue limit calculations (MACO) using PDE, therapeutic dose, and toxicological data.
• Implement cleaning verification strategies, including hold time studies, swab/rinse sampling, and recovery studies.
• Lead validation lifecycle management, including revalidation and continuous improvement initiatives.
• Collaborate with QA, Manufacturing, QC, and Engineering to coordinate validation with minimal production impact.
• Review and approve SOPs, batch records, and validation documents.
• Investigate cleaning validation deviations and develop CAPAs.

Required qualifications:

• 3-5 years of experience in cleaning validation in a cGMP or regulated industry (pharma preferred).
• Knowledge of ASTM E2500 and leveraging verification processes.
• Experience working with QA, Engineering, and Manufacturing teams to streamline processes.
• BA/BS in a related field (e.g., Chemistry, Chemical Engineering) with 3+ years in complex Pharma/cGMP projects.
• Strong communication skills, proactive problem-solving, and a positive, detail-oriented attitude.
• Ability to escalate issues and drive progress in a fast-paced environment.

Job Type: Contract

Pay: $50.00 per hour

Expected hours: 40 per week

Benefits:

• Health insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Experience:

• CGMP: 5 years (Required)
• GLP: 5 years (Required)
• Concept validation: 6 years (Required)

Work Location: On the road