Validation Consultant

Artech Information System LLC; Zebulon (NC); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading IT staffing company in Zebulon, North Carolina, seeks an experienced validation specialist. This role involves ensuring compliance with regulatory requirements, overseeing the commissioning and validation of manufacturing processes in the Pharmaceutical industry, and collaborating with cross-functional teams. The ideal candidate should have a degree in a related field, extensive experience in validation, and strong project management skills. This position offers a unique opportunity to contribute to the improvement of critical systems in a dynamic environment.

Qualifications

• Expertise in regulatory compliance and validation.
• Minimum 3 years experience in Manufacturing validation.
• Knowledge of cGMP regulations.

Responsibilities

• Ensure compliance with regulatory requirements for commissioning.
• Develop and maintain Project Validation Master Plans.
• Collaborate with Engineering on validation protocols.

Skills

Regulatory compliance expertise

Project management

Documentation skills

Communication skills

Computer skills (MS Word, Excel, PowerPoint)

Education

BA/BS in a technical or scientific discipline + 5 years Pharmaceutical experience

MS + 3 years Pharmaceutical experience

2 years Pharmaceutical QA experience

Job description

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.

Job Description

Job Purpose and Key Responsibilities: (Why jobexists/what it must achieve)

• Ensure that the GSK Zebulon - Building Management System (BMS) Replacement Project commissioning / validation program smeet all regulatory and local requirements. Responsible for the development, planning, and implementation of commissioning, qualification and validation for the manufacturing, packaging, facilities, computer controls, and cleaning processes.
• Write, review and execute documentation to conduct all commissioning and / or validation activities to support equipment modification / upgrade projects and maintain existing validated states.
• Requires expertise in regulatory compliance,ability to determine requirements to validate and discern appropriate level of validation for the process.
• Responsible for driving all aspects of the Commissioning Life Cycle and / or Validation Life Cycle from design throug hoperation and improvement. Develop, update, and maintain the Project Validation Master Plans and Project Commissioning Mast Plans.
• Coordinate resources needed to complete commissioning and / or validation tests. Provide commissioning / validation support during the design, evaluati on, and procurement stages. Monitor commissioning /validation criteria and assure compliance.
• Collaborate with Engineering on the developmentof Installation and Operational Qualification documents. Write and execute process, packaging, computer,facility, and cleaning validation protocols and summary reports.
• Interface with Manufacturing, Packaging, Logistics, Engineering, and external vendors to facilitate and drive protocol execution. Author, review, revise, or approve Standard Operating Procedures (SOPs) as required. Maintain up to date knowledge of commissioning and validation requirements, practices, and procedures and instruct other members of the project team. Develop and implement improvement initiatives with filling/packaging/computer and facility/utility validation activities.
• Manage simultaneous projects.Participate on cross-functional teams, who address specific problems, facilitate discussion and research, enabling procedures to become more efficient, and to build and enhance inter departmental relationships. Specialized Knowledge: (breadth & depthacross disciplines or functions; expertise in field required) Bachelors degree in a technical or scientific discipline or related work experience. Minimum 3 years experience in Manufacturingvalidation and the Pharmaceutical or Healthcare Industry required Workingknowledge of cGMP regulations
• In depth knowledge of process, packaging,facility, and cleaning validation Good computer skills and Microsoft Word,Excel, and PowerPoint. Quality and detail oriented with documentation skills. Excellent written and oral communication skills.Ability to develop and facilitate validation training Flexibility to work extended hours to achieve results.
• Prior experience at the Zebulon site andpossession of current hard badge are preferred.
  

Qualifications

• BA/BS + 5 years Pharmaceutical exp.
• MS + 3 years Pharmaceutical exp.
• 2 years Pharmaceutical QA exp.
• Knowledge of cGMP’s/FDA and other Regulatoryrequirements, and Quality Systems
• Knowledge of Engineering Technology Advanced understanding and skills with MS Word,and Excel

Work

Experience

Proven project management experience in leading,researching, developing, data analysis, and executing GMP / System Life Cycle /Validation documentation and reports for utilities system (VP, Commissioning,IQ, OQ, PQ)

Hands on validation experience utilities system sand supporting automation processes including HVAC, Compressors, Water systems,Dust collectors, Building Management System(BMS) (Rockwell Automation, GEMS),Environmental Monitoring Systems (EMS) (Rockwell Automation, GEMS), Lab instrumentation, Temperature and humidity profiling, (facilities, chambers,process equipment) Ability to perform calibrations and generatecalibration reports