Validation & Engineering Group
LL01-241216 Commissioning and Qualification (C&Q) Specialist Utilities and Faci
Validation & Engineering Group, New Albany, Ohio, United States, 43054
Commissioning And Qualification (C&Q) Specialist
Utilities And Facilities
We are looking for 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: 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), and 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). 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. 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. 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: 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. 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. 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.
Utilities And Facilities
We are looking for 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: 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), and 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). 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. 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. 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: 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. 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. 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.