Cleaning Validation Specialist Pharma / GMP Position Available In Wake, North Carolina

Cleaning Validation Specialist – Pharma / GMP Systems Ally Holly Springs, NC Job Details Contract $50 – $70 an hour 9 hours ago Qualifications

CGMP SIP

(Steam-in-Place) GMP Mid-level 3 years Bachelor’s degree Continuous improvement Cleaning Communication skills Method validation Full Job Description No C2C. Looking for cleaning validation specialist with 3-5 years of experience in the Pharma industry

Roles & Responsibilities:

Lead the preparation of all Cleaning Validation documentation, including Master Plans, Protocols (IQ/OQ/PQ), and Final Reports. Develop and execute cleaning validation protocols for manufacturing equipment, CIP/SIP systems, and utilities. Conduct risk assessments and gap analyses of cleaning procedures and historical data to ensure compliance with regulatory standards (FDA, EMA, WHO). Define and implement cleaning verification and validation strategies, such as hold time studies, swab/rinse sampling, recovery studies, and worst-case product matrix determinations. Perform residue limit calculations (MACO), using PDEs, therapeutic doses, and toxicological data. Oversee the full cleaning validation lifecycle, including revalidation criteria and continuous improvement initiatives. Collaborate with QA, Manufacturing, QC, and Engineering to ensure validation activities are executed with minimal impact on production. Review and approve cleaning SOPs, batch records, validation protocols, and reports. Investigate cleaning validation failures or deviations and author corresponding CAPAs.

Required Experience & Skills:

Subject Matter Expert (SME) in Cleaning Validation with 3-5 years of hands-on experience. Strong understanding of ASTM E2500 and Leveraging Verification principles. Experience working cross-functionally with QA, Engineering, and other departments to align validation efforts. Background in cGMP environments or other highly regulated industries, ideally involving large-scale projects or GMP manufacturing facilities. Demonstrated ability to take initiative, drive tasks forward, and contribute to project momentum. Excellent communication and escalation skills. Bachelor’s degree in a relevant field with 3+ years of experience managing complex projects in a pharmaceutical or GMP-compliant setting. Positive, proactive attitude with a collaborative approach. • Summary As a Cleaning Validation Specialist, you will be integral to ensuring compliance with GMP and CGMP standards within our organization. Reporting to the Quality Assurance Manager, your primary responsibility will be to develop and execute cleaning validation protocols, ensuring that all cleaning processes meet regulatory requirements. Your strong communication skills will facilitate collaboration with cross-functional teams, while your expertise in cleaning methodologies will drive continuous improvement. This role is essential in maintaining product quality and safety, contributing to our commitment to excellence in the pharmaceutical industry.

Job Type:

Contract Pay:

$50.00 – $70.00 per hour

Schedule:

8 hour shift Monday to

Friday Work Location:

In person