Senior CQV Engineer

Senior CQV Engineer (Commissioning, Qualification & Validation)

Raritan, NJ | 100% Onsite

$60-$65/hr W2 | Long-Term Contract, 6 months with potential for conversion or extension

Piper Companies is seeking a Senior CQV Engineer to support a leading cell therapy manufacturing organization in Raritan, NJ. This individual will play a critical role in 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, and process equipment within regulated pharmaceutical, biotechnology, cell therapy, or aseptic manufacturing environments. This position requires a highly organized professional capable of managing multiple complex CQV projects simultaneously while collaborating closely with Quality, Manufacturing, Engineering, and Validation teams.

• 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
• Support qualification strategies for clean rooms, 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 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 mentorship and technical guidance to junior CQV team members
• Assist with internal and external audit preparation and support inspection readiness initiatives

• Bachelor's Degree in Engineering, Life Sciences, or related technical discipline
• 8+ years of Commissioning, Qualification, and Validation (CQV) experience within a regulated pharmaceutical, biotechnology, cell therapy, or biologics manufacturing environment
• Demonstrated experience managing multiple complex CQV projects simultaneously (minimum of three concurrent projects)
• 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
• Excellent communication skills with the ability to clearly articulate technical decisions and project status to stakeholders

• Cell Therapy or CAR‑T manufacturing experience
• Experience supporting aseptic manufacturing environments
• Experience with Grade A, Grade B, and Grade C cleanroom qualification
• 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 Val Probe

• 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

Successful candidates will be able to clearly communicate how they have:

• Developed qualification strategies for facilities, utilities, or equipment
• Managed competing priorities across multiple validation projects
• Led complex deviation investigations and implemented corrective actions
• Collaborated with Quality and cross‑functional stakeholders to drive compliant solutions
• Supported manufacturing operations in highly regulated environments