Source description
About the role
Title: CIP Specialist Location: Raleigh, NC (Onsite)
Experience: 10+ years
Role Overview
We are seeking a CIP Specialist to oversee and guide a team responsible for Clean-in-Place (CIP) activities, including shakedown, troubleshooting, cycle parameter development, cycle runs, and process performance. This role requires hands-on technical expertise along with leadership skills to supervise staff, coordinate cross-functional projects, and collaborate with clients and vendors. Assignments are broad in scope and allow for independent judgment and decision-making.
Key Responsibilities
Serve as the subject matter expert for CIP-related engineering projects, start-up, and cycle development.
Lead and direct technical staff in the execution of various CIP projects.
Review engineering specifications for compliance with regulations and technical requirements.
Develop and implement cleaning cycle strategies for equipment such as process vessels, lines, chromatography skids/columns, UF/DF skids, centrifuges, glass/parts washers, and portable processing equipment.
Conduct CIP shakedowns, troubleshooting, parameter adjustments, and cycle runs.
Perform hydraulic and piping design calculations, including flow rate, Reynolds number, and pump sizing.
Provide commissioning and automation support for CIP systems, including PLC and SCADA/DeltaV platforms.
Review batch records, ensuring calibration and in-process data accuracy.
Prepare and deliver technical reports, documentation, and summary findings.
Consult with clients and vendors to address technical challenges and project developments.
Contribute to project management activities within engineering programs.
Required Qualifications
Bachelor’s degree in Chemical Engineering or related field.
Minimum 10 years of experience in pharmaceutical manufacturing or GMP-regulated environment.
Proven expertise in CIP cycle development, cleaning validation, protocol development, execution, troubleshooting, and reporting.
Hands-on experience with CIP shakedown, troubleshooting, and parameter adjustments.
Strong knowledge of hydraulic calculations (flow rate, Reynolds number, pump sizing).
Familiarity with plant control systems, including PLC and SCADA/DeltaV.
Experience in engineering project management.
Excellent communication and documentation skills.
Proficient with Microsoft Office Suite.
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