CQV Specialist Position Available In Wake, North Carolina

CQV Specialist Job Employer Name:

ND Global Consulting Services Inc

SpiderID:

13939688

Location:

Apex, North Carolina

Date Posted:

2/6/2025

Wage:

88462

Category:

Engineering

Job Code:

Number Of Openings:

1

Job Description:

CQV Specialist is needed to perform the following duties:

• Responsible for all aspects of validation processes like- documenting commissioning activities, establishing the process and developing and performing qualification studies to provide a high degree of assurance that equipment and processes will consistently produce a drug product meeting its pre-determined specifications along with quality attributes.
• Demonstrate experience in electronic validation, which is considered a valuable asset for this role:
• Ensure compliance with industry standards for electronic records and signatures (21 CFR Part 11) during the validation process.
• Assist in the design, testing, and validation of electronic systems that control process equipment, ensuring they meet all regulatory and operational requirements.
• Utilize a comprehensive understanding of equipment functionality to conduct detailed troubleshooting and commissioning activities:
• Leverage expertise in mechanical and electrical systems to troubleshoot and optimize equipment performance.
• Perform comprehensive assessments during commissioning to ensure equipment meets all functional and safety requirements.
• Troubleshoot operational issues and provide corrective actions during equipment startup and testing phases.
• Coordinate with cross-functional teams to ensure timely resolution of technical issues and smooth system integration.
• Development/Execution qualification
• (Commissioning/IOQ/IQ/OQ/PQ), Standard operating procedures (SOP), and specifications
  for Lab systems/Instrument/Equipment.
• Performed temperature mapping using the KAYE (2000) and Data loggers.
• Validate control temperature units like controlled freezers, Lyophilizers, Autoclaves, Parts Washers, Isolators, refrigerator, Autoclaves, TCU’s, Serialization equipment – vial filling machine.
• Leverage previous experience in Commissioning, Qualification, and Validation (CQV) to support effective project execution:
• Apply extensive knowledge of CQV procedures to ensure all systems are validated according to regulatory standards and company protocols.
• Engage with bioreactors, centrifuges, buffers, media, chromatography systems, and tangential flow filtration (TFF):
• Oversee the operation and maintenance of bioreactors, centrifuges, and other bio-processing equipment to support production processes.
• Manage and optimize the performance of chromatography systems and tangential flow filtration (TFF) systems to maximize yield and product quality.
• Apply your strong engineering background to interpret Piping & Instrumentation Diagrams (P&IDs), operate pumps and motors, and verify the proper commissioning of equipment:
• Utilize advanced engineering skills to interpret and analyze P&IDs to ensure proper system layout and design functionality.
• Operate and test pumps, motors, valves, and related equipment to ensure smooth commissioning and functionality in operational environments.
• Ensure that all commissioning activities, including system integration and equipment testing, meet operational standards.
• Support functions including formulation, aseptic filling, isolators, and lyophilizers:
• Provide support and technical expertise in formulation processes, ensuring compliance with Good Manufacturing Practices (GMP).
• Work closely with aseptic filling operations to ensure that all processes are sterile, minimizing risk of contamination.
• Operate and troubleshoot isolators and Lyophilizers to maintain the integrity of biologics and pharmaceuticals.
• Assist in ensuring the proper handling, packaging, and storage of products to maintain regulatory compliance and product quality.
• Assist with operations related to parts washers, autoclaves, and temperature control units (TCUs): Oversee the operation of parts washers and autoclaves, ensuring that all cleaning and sterilization procedures are performed according to specifications.
• Utilize hands-on experience with process equipment—including tanks, piping, and pumps—to ensure operational efficiency: Oversee the installation, operation, and maintenance of process equipment such as tanks, pumps, and piping systems.
• Ensure that all equipment operates within predefined parameters and that any issues are addressed promptly to maintain production schedules.
• Conduct preventive maintenance and troubleshooting to maximize operational efficiency and reduce downtime.
• Documentation include, but not limited to: Life cycle documents created and manage Risk Assessments, Validation Plans, Design Specifications, User Requirements, Function-al Requirements, IOQ, IQ/OQ/PQ Protocols, Requirements Traceability Matrices, Summary Reports, change control, CAPA, Exceptional condition and risk assessments.
• Developing and executing validation protocols maintaining Data integrity and ALCOA principles are essential to for a complaint paper and/or electronic data management life cycle system, complying
  with GDPs, complying with GMPs, and driving data integrity initiatives.
• Original data is the paper or electronic medium in which the data point is initially recorded including protocol, database, or software application.

Understanding where the original data is generated to ensure content and meaning are preserved.

Job Requirements:

Bachelor’s Degree is required in Pharmaceutical Engineering or Pharmacy or Pharmaceutical Science.

Job Criteria:

Start Date:

02/17/2025

Position Type:

Full-Time Permanent

Years of Experience Required:

1

Education Required:

Bachelors

Overnight Travel:

Vacation Time:

Job Benefits:

Health/Dental Benefits, Paid Holidays, Vacations, and Sick Leave Contact Information:

Contact Name:

Rashmi Kumari

Company Type:

Staffing Agency

Company:

ND Global Consulting Services Inc City:

Tampa State:

Florida Zip:

33647