Unicon Pharma Inc
Overview
We are seeking a detail-oriented and technically strong CQV Engineer – CIP Systems to support Commissioning, Qualification, and Validation (CQV) activities focused on Clean-in-Place (CIP) systems within a regulated CDMO facility. This role will support the delivery of equipment and system readiness from installation through qualification, ensuring all validation efforts are completed by project timelines and compliance requirements. Location:
North Carolina (100% Onsite) Start:
ASAP (rolling starts) Duration:
6 months to start (possibility of extension based) Hours:
~40 hrs/week (flexible with various shifts) Salary:
Base pay range $45.00/hr - $60.00/hr; actual pay based on skills and experience Key Responsibilities
Lead or support the commissioning and qualification of CIP skids and associated process equipment. Prepare and execute CQV documentation, including FAT, SAT, IOQ protocols, and final summary reports for CIP systems. Support integration and qualification of CIP systems with upstream/downstream manufacturing and utility systems. Perform field verification of equipment installations and support troubleshooting activities during start-up. Draft and review validation protocols (URS, DQ, IOQ) in alignment with current GMP and regulatory guidelines. Ensure all documentation meets data integrity, traceability, and document control standards. Interface with QA for review and approval of qualification deliverables. Assist with deviation management and change control processes related to CIP systems. Collaborate closely with engineering, QA, manufacturing, and automation teams. Provide technical input to vendors and support coordination of testing activities. Participate in daily project meetings and support the CQV team with updates and action item tracking. Qualifications & Experience
Bachelor’s degree in chemical, mechanical, or biotech engineering or a related field. 3–6 years of experience in CQV, with specific experience working on CIP systems in a GMP-regulated pharmaceutical/CDMO environment. Relevant experience in (bioreactors, chromatography skids, UF/DF, TFF, autoclaves, parts washers, etc.) OR (CTU - fridges, freezers, incubators, etc.). Strong knowledge of process equipment and cleaning validation requirements. Experience with control systems, automation integration, and troubleshooting for CIP systems. CQV Engineer/Specialist should include upstream and downstream bioprocess equipment in addition to CIP. Bonus: Experience with Operational Verification (OV) and Operations Qualification (OQ) experience & experience with Kneat. Familiarity with regulatory standards including FDA, EMA, and ICH guidelines. Excellent technical writing and communication skills. Proficiency in MS Office, and experience with validation lifecycle tools/document control systems. Note:
If the job is posted, resumes are still being accepted.
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We are seeking a detail-oriented and technically strong CQV Engineer – CIP Systems to support Commissioning, Qualification, and Validation (CQV) activities focused on Clean-in-Place (CIP) systems within a regulated CDMO facility. This role will support the delivery of equipment and system readiness from installation through qualification, ensuring all validation efforts are completed by project timelines and compliance requirements. Location:
North Carolina (100% Onsite) Start:
ASAP (rolling starts) Duration:
6 months to start (possibility of extension based) Hours:
~40 hrs/week (flexible with various shifts) Salary:
Base pay range $45.00/hr - $60.00/hr; actual pay based on skills and experience Key Responsibilities
Lead or support the commissioning and qualification of CIP skids and associated process equipment. Prepare and execute CQV documentation, including FAT, SAT, IOQ protocols, and final summary reports for CIP systems. Support integration and qualification of CIP systems with upstream/downstream manufacturing and utility systems. Perform field verification of equipment installations and support troubleshooting activities during start-up. Draft and review validation protocols (URS, DQ, IOQ) in alignment with current GMP and regulatory guidelines. Ensure all documentation meets data integrity, traceability, and document control standards. Interface with QA for review and approval of qualification deliverables. Assist with deviation management and change control processes related to CIP systems. Collaborate closely with engineering, QA, manufacturing, and automation teams. Provide technical input to vendors and support coordination of testing activities. Participate in daily project meetings and support the CQV team with updates and action item tracking. Qualifications & Experience
Bachelor’s degree in chemical, mechanical, or biotech engineering or a related field. 3–6 years of experience in CQV, with specific experience working on CIP systems in a GMP-regulated pharmaceutical/CDMO environment. Relevant experience in (bioreactors, chromatography skids, UF/DF, TFF, autoclaves, parts washers, etc.) OR (CTU - fridges, freezers, incubators, etc.). Strong knowledge of process equipment and cleaning validation requirements. Experience with control systems, automation integration, and troubleshooting for CIP systems. CQV Engineer/Specialist should include upstream and downstream bioprocess equipment in addition to CIP. Bonus: Experience with Operational Verification (OV) and Operations Qualification (OQ) experience & experience with Kneat. Familiarity with regulatory standards including FDA, EMA, and ICH guidelines. Excellent technical writing and communication skills. Proficiency in MS Office, and experience with validation lifecycle tools/document control systems. Note:
If the job is posted, resumes are still being accepted.
#J-18808-Ljbffr