Senior CQV Engineer

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 9/24/2026. Applications for this job will be accepted for at least 30 days from the posting date.

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