Senior Validation Engineer

Position: Senior Cleaning Validation Engineer

Job Summary

We are seeking an experienced Cleaning Validation Engineer with at least 5 years of hands-on experience in pharmaceutical or biopharmaceutical manufacturing. The ideal candidate must have strong, genuine experience with Cleaning-in-Place (CIP), Sterilization-in-Place (SIP), cleaning validation, and equipment qualification within a GMP-regulated environment.

Key Responsibilities


- Develop and execute cleaning validation protocols, reports, and procedures.
- Lead cleaning validation activities for manufacturing equipment, vessels, tanks, transfer lines, and process systems.
- Support and troubleshoot CIP and SIP systems, including cycle development and optimization.
- Develop cleaning strategies, acceptance criteria, sampling plans, and worst-case assessments.
- Execute IQ/OQ/PQ and cleaning validation studies in accordance with GMP requirements.
- Perform sampling, swab/rinse recovery studies, and evaluate analytical results.
- Investigate cleaning validation failures, deviations, OOS/OOT results, and CAPAs.
- Prepare and review validation documentation, risk assessments, and technical reports.
- Collaborate with Manufacturing, Quality, Engineering, Automation, and QC teams.
- Ensure validation activities comply with FDA, cGMP, and applicable regulatory requirements.


Required Qualifications


- 5+ years of hands-on Cleaning Validation experience in pharmaceutical, biotech, or regulated manufacturing.
- Strong experience with CIP and SIP systems is required.
- Experience with IQ/OQ/PQ and equipment qualification.
- Strong understanding of GMP and FDA validation requirements.
- Experience with tanks, vessels, piping, process equipment, and automated cleaning systems.
- Strong technical writing, documentation, and troubleshooting skills.
- Bachelor’s degree in Engineering, Chemistry, Life Sciences, or a related field preferred.