Cleaning Validation Engineer

Job Title: Cleaning Validation Engineer Location: Worcester County, MA Employment Type: Contract (W2) Duration: 12 Months Rate: $54–$59/hr W2 About the Role We are seeking a Cleaning Validation Engineer with strong hands-on experience supporting cleaning validation and process qualification in pharmaceutical or biotech manufacturing environments. The role will lead cleaning validation activities, troubleshooting, risk assessments, and continuous process verification across GMP operations. Key Responsibilities Lead cleaning validation and verification activities for CIP, COP, and manual cleaning processes.Develop and execute cleaning validation protocols, risk assessments, reports, and technical studies.Support cleaning process design, development, optimization, and troubleshooting.Establish and evaluate Dirty Hold Time (DHT) and Clean Hold Time (CHT).Perform risk-based cleaning assessments, including worst-case selection, equipment trains, cleaning agents, and analytical methods.Investigate cleaning deviations, incidents, and OOS results and perform root-cause analysis.Support NPI, technology transfer, process improvement, and continued process verification.Collaborate with Manufacturing, Engineering, Facilities, QC, QA, and Operations teams.Maintain validated cleaning processes and ensure GMP and regulatory compliance. Required Qualifications Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Chemistry, Biology, Chemical Engineering, or related discipline.5+ years of hands-on cleaning validation experience in pharmaceutical or biotech environments.Strong experience with CIP, COP, and manual cleaning processes.Knowledge of cleaning validation, risk assessment, DOE, analytical/sampling methods, and troubleshooting.Experience writing, reviewing, and executing cleaning validation/verification protocols.Strong understanding of GMP and regulatory requirements.Experience with ASTM E2500 and sterile/aseptic or CDMO operations preferred.Strong project leadership, analytical, technical writing, and problem-solving skills. Salary The hourly rate for this position is $54–$59 per hour. Benefits This is a contract position and does not include employer-provided benefits. Equal Opportunity Employer We are an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. Background Check Background checks may be conducted in accordance with applicable law. Work Authorization Applicants must be authorized to work in the United States.