Validation Consultant

Overview

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 Purpose and

Key Responsibilities:

(Why job exists/what it must achieve)

• Ensure that the GSK Zebulon - Building Management System (BMS) Replacement Project commissioning / validation program meet 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 through operation and improvement. Develop, update, and maintain the Project Validation Master Plans and Project Commissioning Master Plans.
• Coordinate resources needed to complete commissioning and/or validation tests. Provide commissioning/validation support during the design, evaluation, and procurement stages. Monitor commissioning/validation criteria and assure compliance.
• Collaborate with Engineering on the development of 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:
  Bachelor’s degree in a technical or scientific discipline or related work experience. Minimum 3 years experience in Manufacturing validation and the Pharmaceutical or Healthcare Industry required. Working knowledge of cGMP regulations.
• In-depth knowledge of process, packaging, facility, and cleaning validation. Good computer skills with 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 and possession of current hard badge are preferred.

• BA/BS + 5 years Pharmaceutical exp.
• MS + 3 years Pharmaceutical exp.
• 2 years Pharmaceutical QA exp.
• Knowledge of cGMP’s/FDA and other Regulatory requirements, 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 with utilities systems and 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 generate calibration reports.