Senior CQV Engineer - 175928

Piper Companies; Raritan (NJ); On-site; USD 170,822,000 - 185,976,000; Part time

Job summary

Piper Companies is seeking a Senior CQV Engineer to support commissioning, qualification and validation activities for cell therapy manufacturing in Raritan, NJ. This onsite role focuses on CQV for facilities, utilities, equipment, and manufacturing systems with direct collaboration across Quality, Manufacturing, Engineering and Validation teams.

The candidate will lead CQV projects, author critical validation documentation, drive risk-based validation strategies, and support inspections and

Qualifications

• 8+ years of CQV experience in regulated pharma/biotech environments.
• Experience managing multiple CQV projects concurrently.
• Experience authoring IQ/OQ/PQ protocols and validation docs.
• Strong knowledge of cGMP and regulatory guidance (FDA/ICH).

Responsibilities

• Execute CQV activities for facilities, utilities, equipment and manufacturing systems.
• Lead multiple CQV projects ensuring timelines, deliverables and compliance.
• Author/review CQV protocols, reports, risk assessments and validation docs.
• Provide technical guidance to junior CQV team members and support audits.

Skills

CQV experience

Project management

Regulatory knowledge

Education

Bachelor's degree in Engineering or Life Sciences

Tools

Maximo

Siemens EMS

Comet

Kneat

Kaye ValProbe

Job description

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.

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