Process Validation Specialist – (Cleaning Validation) Position Available In Wake, North Carolina
Tallo's Job Summary: Process Validation Specialist - (Cleaning Validation) position in Systemsally, Holly Springs, NC. This contract job offers $50 - $70 an hour. The role requires 3-5+ years of experience in Cleaning Validation within a GMP-regulated environment, expertise in cleaning validation principles, and a Bachelor's degree in a related field. Responsibilities include developing validation documentation, executing cleaning validation activities, and collaborating cross-functionally.
Job Description
Process Validation Specialist – (Cleaning Validation) Systemsally Holly Springs, NC Job Details Contract $50 – $70 an hour 8 hours ago Qualifications CGMP Validation assurance (scale-up process) Process optimization GMP Mid-level 3 years Bachelor’s degree Process validation (IQ/OQ/PQ) Cleaning Communication skills FDA regulations Engineering validation Full Job Description N o C2C. W2 Only Looking for a cleaning validation specialist to work on-site in NC Key Responsibilities Develop, lead, and manage cleaning validation documentation including master plans, protocols (IQ/OQ/PQ), and reports. Execute cleaning validation activities for manufacturing equipment, CIP/SIP systems, and utility systems. Conduct risk assessments and gap analyses on existing cleaning processes and historical data.
Establish robust cleaning validation strategies:
hold time studies, swab/rinse sampling, recovery studies, and worst-case scenario analysis. Perform residue limit calculations (MACO) using PDE, therapeutic dose, and toxicological data. Own the cleaning validation lifecycle, including revalidation planning and continuous improvement initiatives. Collaborate cross-functionally with QA, QC, Engineering, and Manufacturing to ensure seamless execution of validation activities. Review and approve cleaning-related SOPs, batch records, validation protocols, and reports. Investigate validation deviations and drive resolution through effective CAPAs. Qualifications 3-5+ years of hands-on experience in Cleaning Validation within a GMP-regulated (FDA, EMA, WHO) environment. Recognized subject matter expertise in cleaning validation principles and practices. Familiarity with ASTM E2500 and risk-based validation approaches. Proven ability to work cross-functionally and influence without authority. Experience supporting large-scale projects or operational GMP facilities. Strong technical writing and documentation review skills. Excellent communication and problem-solving abilities. Bachelor’s degree in a scientific or engineering discipline. Self-starter with a positive, can-do attitude and commitment to delivering results.
Job Type:
Contract Pay:
$50.00 – $70.00 per hour
Schedule:
8 hour shift
Work Location:
In person
