Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Commissioning and Qualification (C&Q) Specialist – Utilities and Facilities

Overview:

We are seeking a highly skilled Commissioning and Qualification (C&Q) Specialist to support a major capital project within the pharmaceutical, biotechnology, or life sciences sector. The role focuses on ensuring that utilities and facilities meet operational readiness, regulatory compliance, and project goals. This position plays a critical role in the successful delivery of validated systems and operational facilities, aligned with cGMP standards and industry regulations.

Key Responsibilities:

Commissioning and Qualification:

• Develop and execute C&Q protocols (IQ/OQ/PQ) for utilities and facilities, including but not limited to:
  • HVAC systems
  • Clean utilities (e.g., WFI, pure steam, compressed air, nitrogen)
  • Critical utilities (e.g., water systems, power systems)
  • Process-support systems (e.g., chillers, boilers)
  • Author, review, and approve commissioning and qualification documentation, such as User Requirement Specifications (URS), Design Qualification (DQ), and Traceability Matrices.
  • Support the development and execution of Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT).

Regulatory Compliance:

• Ensure that utilities and facilities meet cGMP, FDA, EU, and other relevant regulatory standards.
• Collaborate with Quality Assurance to ensure all documentation and processes comply with validation lifecycle requirements.
• Drive risk assessments, such as Failure Modes and Effects Analysis (FMEA) or Risk-Based Approach to qualification.

Project Management and Collaboration:

• Work closely with engineering, quality, and operations teams to support seamless project execution.
• Manage schedules and timelines for commissioning and qualification activities, ensuring alignment with the overall project plan.
• Provide support for system start-up and troubleshooting during project execution.

Documentation and Reporting:

• Maintain accurate and detailed documentation throughout the commissioning and qualification lifecycle.
• Prepare and deliver progress reports, issue logs, and C&Q summary reports to project stakeholders.
• Coordinate resolution of non-conformances and deviations identified during commissioning and qualification activities.

Qualifications:

Education and Experience:

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
• Minimum 3 years of experience in commissioning, qualification, and validation in the pharmaceutical, biotechnology, or life sciences industries.
• Hands-on experience with utilities and facilities commissioning/qualification, including cleanroom environments and GMP-regulated systems.

Technical Skills:

• Expertise in C&Q practices aligned with ISPE Baseline Guide Volume 5, ASTM E2500, and GAMP5 methodologies.
• Familiarity with clean utility systems and regulatory expectations for utilities and facilities.
• Proficient in Microsoft Office Suite and validation software tools.

Soft Skills:

• Strong analytical, problem-solving, and organizational skills.
• Excellent written and verbal communication skills, with the ability to present complex concepts clearly.
• Ability to work collaboratively in a fast-paced, multidisciplinary team environment.

Preferred Qualifications:

• Certified in Lean Six Sigma, Project Management (PMP), or related discipline.
• Experience working on large-scale capital projects and understanding of engineering design and construction phases.
• Knowledge of regulatory inspections and audit readiness for utilities and facilities.