Senior CQV Engineer – Pharma Facilities & Validation (Onsite)

Piper Companies; Titusville (NJ); On-site; USD 83,000 - 90,000; Full time

Job summary

Piper Companies is seeking a Senior CQV Engineer (CQV) to support a leading pharmaceutical client in Titusville, NJ. This 6-month contract is 100% onsite, with compensation of $60–$65 per hour W2.

The role covers commissioning, qualification, validation, remediation, and compliance across facilities, utilities, laboratory equipment, and manufacturing systems in a cGMP setting. Strong CQV expertise and regulatory familiarity are essential.

Qualifications

• 8+ years of CQV experience within a regulated pharmaceutical, biotechnology, or life sciences environment.
• Experience authoring and executing IQ/OQ/PQ protocols and lifecycle qualification documentation.
• Strong understanding of risk-based qualification strategies, validation lifecycle management, and change control.
• Knowledge of cGMP requirements and applicable FDA, EU, and ICH guidance.
• Familiarity with 21 CFR Parts 210 and 211; knowledge of Part 11 and other applicable regulations is beneficial.

Responsibilities

• Execute commissioning, qualification, requalification, and validation activities for facilities, utilities, process equipment, laboratory equipment, and manufacturing systems.
• Manage multiple CQV projects simultaneously, ensuring project timelines, deliverables, and compliance requirements are met.
• Author, review, execute, and approve IQ/OQ/PQ protocols, qualification reports, risk assessments, and supporting documentation.
• Support qualification of laboratory equipment and systems used in pharmaceutical testing and stability programs, including controlled temperature units and stability chambers, where applicable.
• Develop and support qualification strategies for facilities, utilities, controlled environments, and critical pharmaceutical manufacturing and laboratory systems.
• Lead or support deviation investigations, root cause analysis, CAPAs, corrective actions, and remediation activities related to CQV.
• Partner with Quality, Laboratory Operations, Engineering, and other stakeholders to resolve technical and compliance issues.
• Support equipment installations, relocations, facility upgrades, and laboratory or manufacturing improvement projects.
• Contribute to change controls, SOP revisions, FMEAs, periodic reviews, and validation master plans.
• Communicate project status, technical decisions, risks, and deliverables to cross-functional stakeholders.
• Support internal and external audits and regulatory inspection readiness.

Skills

CQV Experience

Regulatory Knowledge

Cross-functional Collaboration

Documentation

Risk-based Qualification

Project Management

Education

Bachelor's degree in Engineering or related technical discipline

Tools

Maximo

Siemens EMS

Kneat

Kaye

ValProbe

Comet

AVS

Job description

Piper Companies is seeking a Senior CQV Engineer (CQV) to support a leading pharmaceutical client in Titusville, NJ. This 6-month contract is 100% onsite, with compensation of $60–$65 per hour W2.

The role covers commissioning, qualification, validation, remediation, and compliance across facilities, utilities, laboratory equipment, and manufacturing systems in a cGMP setting. Strong CQV expertise and regulatory familiarity are essential.