Senior CQV Engineer – Commissioning, Qualification & Validation Contract: 6 months with potential for extension or conversion Location: Raritan, NJ Work Arrangement: 100% Onsite Compensation: $60–$65/hour W2 About the Opportunity Piper Companies is seeking an experienced Senior CQV Engineer (Commissioning, Qualification & Validation) to support a leading cell therapy manufacturing organization in Raritan, NJ. This individual will play a critical role supporting commissioning, qualification, validation, remediation, and compliance activities within a cGMP clinical and commercial manufacturing environment. The ideal candidate will have extensive experience qualifying facilities, utilities, process equipment, and manufacturing systems within a regulated pharmaceutical, biotechnology, cell therapy, biologics, or aseptic manufacturing environment. This is a highly hands-on role requiring a technically strong and organized professional who can manage multiple complex CQV projects simultaneously while partnering closely with Quality, Manufacturing, Engineering, and Validation teams. Key Responsibilities • Execute commissioning, qualification, requalification, and validation activities for facilities, utilities, equipment, and manufacturing systems. • Lead and manage multiple CQV projects simultaneously, ensuring timelines, deliverables, and compliance requirements are met. • Author, review, execute, and approve CQV protocols, reports, risk assessments, and supporting documentation. • Develop and support qualification strategies for cleanrooms, controlled environments, utilities, process equipment, and manufacturing systems. • Drive investigations, deviations, CAPAs, corrective actions, and remediation efforts from a CQV perspective. • Partner with Quality and cross-functional stakeholders to resolve complex technical and compliance issues. • Support equipment relocations, facility upgrades, and manufacturing expansion projects. • Participate in smoke studies, airflow visualization studies, environmental qualification activities, and cleanroom validation efforts. • Contribute to change controls, SOP revisions, FMEAs, periodic reviews, and validation master plans. • Provide technical guidance and mentorship to junior CQV team members. • Support internal and external audit preparation and inspection-readiness initiatives. • Clearly communicate technical decisions, project status, risks, and deliverables to cross-functional stakeholders. Qualifications • Bachelor's degree in Engineering, Life Sciences, or a related technical discipline. • 8+ years of Commissioning, Qualification, and Validation (CQV) experience within a regulated pharmaceutical, biotechnology, cell therapy, biologics, or similar manufacturing environment. • Demonstrated experience managing multiple complex CQV projects simultaneously, with a minimum of three concurrent projects preferred. • Strong experience in at least two of the following areas: • Facilities Qualification • Utilities Qualification • Process Equipment Qualification • QC Equipment Qualification • Controlled Temperature Units (CTUs) • Computerized Systems Validation (CSV) exposure • Experience authoring and executing IQ/OQ/PQ protocols and validation lifecycle documentation. • Experience leading or supporting deviation investigations, root cause analysis, CAPAs, and remediation activities. • Strong understanding of qualification strategy, risk-based validation approaches, and lifecycle management. • Strong communication skills with the ability to articulate technical decisions and project status to stakeholders. • Strong knowledge of cGMP and cGTP regulations. • Understanding of FDA, EU, ICH, and applicable regulatory guidance. • Experience working within highly regulated manufacturing environments supporting patient-specific therapies. • Familiarity with 21 CFR Parts 210, 211, and 1271; knowledge of Parts 600, 601, and 610 is a plus. Preferred Experience • Cell Therapy or CAR-T manufacturing experience. • Experience supporting aseptic manufacturing environments. • Grade A, Grade B, and Grade C cleanroom qualification experience. • Glovebox qualification experience. • Smoke study and airflow visualization experience. • Experience with equipment upgrades, facility modifications, and equipment relocation projects. • Experience supporting regulatory inspections or internal audits. • Familiarity with: • Maximo • Siemens EMS • Comet • Kneat • Kaye • AVS • Kaye ValProbe What We're Looking For Successful candidates will be able to demonstrate experience with: • Developing qualification strategies for facilities, utilities, or equipment. • Managing competing priorities across multiple validation projects. • Leading complex deviation investigations and implementing corrective actions. • Collaborating with Quality and cross-functional stakeholders to drive compliant solutions. • Supporting manufacturing operations within highly regulated environments. • Managing CQV deliverables while maintaining project timelines and regulatory compliance. Work Environment This position is 100% onsite in Raritan, NJ and requires an experienced CQV professional who can work closely with Manufacturing, Quality, Engineering, and Validation teams in a hands-on manufacturing environment. This job opens for applications on 10/6/2026. Applications for this job will be accepted for at least 30 days from the posting date. #LI-KP1 #LI-ONSITE