Title: Cleaning Validation Engineer
Location: Worcester County, MA
Duration: 12 Months
Pay Rate: $55 $58/hr
Experience: 5+ Years
Job Summary
Seeking an experienced Cleaning Validation Engineer to lead cleaning validation activities within a pharmaceutical/biotech manufacturing environment. The ideal candidate will have strong hands-on experience with CIP, COP, Manual Cleaning, cleaning process qualification, risk assessments, and cleaning validation lifecycle activities.
Key Responsibilities
- Lead cleaning validation activities for new and existing manufacturing equipment/processes.
- Develop and execute cleaning validation/verification protocols, risk assessments, and technical reports.
- Support CIP, COP, and Manual Cleaning process design, development, and qualification.
- Establish Dirty Hold Time (DHT) and Clean Hold Time (CHT) studies.
- Support analytical/sampling methods, recovery studies, cleaning agents, and worst-case assessments.
- Investigate cleaning deviations, OOS results, and perform root cause analysis.
- Maintain validated cleaning processes through continued process verification (CPV).
- Support NPI/Technology Transfer and evaluate cleaning requirements for new products and equipment.
- Partner with Manufacturing, Engineering, Operations, QC, and QA teams.
Requirements
- Bachelor's or Master's degree in Life Sciences, Pharmacy, Chemistry, Biology, Chemical Engineering, or related discipline.
- 5+ years of direct Cleaning Validation experience within pharmaceutical/biotech manufacturing.
- Strong hands-on experience with CIP, COP, and Manual Cleaning.
- Experience with cleaning validation protocols, risk assessments, DHT/CHT, sampling/analytical methods, and recovery studies.
- Strong knowledge of cGMP and cleaning validation regulatory requirements.
- Experience with DOE, troubleshooting, deviations, and technical report writing.
- Strong project leadership and cross-functional communication skills.
- Experience with ASTM E2500, sterile/aseptic operations, CDMO environments, and ISPE Cleaning Validation preferred.