CQV Engineer

Piper Companies; Titusville (NJ); Vor Ort; USD 83.000 - 90.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

CQV Experience

Regulatory Knowledge

Cross-functional Collaboration

Documentation

Risk-based Qualification

Project Management

Ausbildung

Bachelor's degree in Engineering or related technical discipline

Tools

Maximo

Siemens EMS

Kneat

Kaye

ValProbe

Comet

AVS

Jobbeschreibung

CQV Engineer – Commissioning, Qualification & Validation

Contract: 6 months with potential for extension or conversion

Location: Titusville, 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 pharmaceutical organization at its Titusville, NJ facility.

This role will support commissioning, qualification, validation, remediation, and compliance activities within a highly regulated pharmaceutical manufacturing and laboratory environment. The site supports small-molecule pharmaceutical operations and onsite stability laboratories, requiring strong CQV expertise across facilities, utilities, laboratory equipment, and manufacturing systems.

The ideal candidate will bring extensive experience qualifying pharmaceutical facilities, process equipment, laboratory systems, and critical utilities in a cGMP environment. Experience supporting stability laboratories, analytical testing environments, controlled temperature units, and equipment qualification is particularly valuable.

This is a hands-on role for a technically strong and organized professional who can manage multiple CQV projects simultaneously while partnering closely with Quality, Laboratory Operations, Manufacturing, Engineering, and Validation teams.

Key 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.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• 8+ years of CQV experience within a regulated pharmaceutical, biotechnology, or life sciences environment.
• Demonstrated ability to manage multiple complex CQV projects concurrently.
• Strong experience in at least two of the following areas:
  • Facilities Qualification
  • Utilities Qualification
  • Process Equipment Qualification
  • QC and Analytical Laboratory Equipment Qualification
  • Controlled Temperature Units (CTUs) and stability chambers
  • Computerized Systems Validation (CSV)
• Experience authoring and executing IQ/OQ/PQ protocols and lifecycle qualification documentation.
• Experience supporting deviation investigations, root cause analysis, CAPAs, and remediation activities.
• 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.
• Strong organizational, documentation, communication, and cross-functional collaboration skills.

Preferred Experience

• Small-molecule pharmaceutical manufacturing experience.
• Qualification of stability chambers, controlled temperature units, and analytical laboratory equipment.
• Experience supporting pharmaceutical stability testing laboratories and QC operations.
• Experience with equipment upgrades, laboratory modifications, and equipment relocation projects.
• Knowledge of cleanroom qualification, environmental monitoring systems, and controlled environments.
• Experience supporting regulatory inspections and internal audits.
• Familiarity with systems and tools such as Maximo, Siemens EMS, Kneat, Kaye, ValProbe, Comet, and AVS.

What We're Looking For

• The successful candidate will be able to develop and execute qualification strategies, manage competing CQV priorities, troubleshoot technical and compliance issues, and collaborate with Quality, Engineering, and Laboratory Operations to maintain a compliant state of control across pharmaceutical manufacturing and laboratory environments.

Work Environment

This position is 100% onsite in Titusville, 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 10/27/2026. Applications for this job will be accepted for at least 30 days from the posting date.