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Softworld Validation Associate-Level 1-5080 in st louis, Missouri

Validation Associate-Level 1-5080

st louis, MO

63102

Posted: 09/21/2020

2020-09-21 2020-11-20

Employment Type: Contract

Industry: ERT

Job Number: 233192

Job Description

Validation Associate

  • Validation Associate wanted for a 6-month contract position open in St. Louis, MO

  • Responsible for the development, planning, implementation, qualification and validation for the manufacturing, packaging, facilities, computer, and cleaning processes in place at the St. Louis Site

  • Write, review, and execute documentation to conduct all validation activities to support new product launches and maintain existing product validations

  • Requires expertise in regulatory compliance, ability to determine requirement to validate and discern appropriate level of validation for the process

  • Determine cause/effect relationship between equipment modifications and product efficiency

  • Responsible for driving all aspects of the Validation Life Cycle in from design through operation and improvement

  • Develop, update, and maintain the Site Validation Master Plan and the Site Computer Validation Master Plan as applicable

  • Coordinate resources needed to complete validation tests

  • Provide validation support during the design, evaluation, and procurement stages

  • Monitor validation criteria and assure compliance

  • Prepare presentations for regulatory agencies regarding the validation program and its status

  • Provide technical expertise and facilitate documentation assembly during regulatory audits

  • Collaborate with Engineering on the development of User Required Specifications and Installation and Operational Qualification documents

  • Participate on cross-functional teams, address specific problems, facilitate discussion and research, enabling procedures to become more efficient, and to build and enhance interdepartmental relationships

Required Skills:

  • Specialized Knowledge: (broad & depth across disciplines or functions; expertise in field required)

  • Bachelor’ s degree in a technical or scientific discipline or related work experience.

  • Minimum 5 years’ experience in Manufacturing validation in the Pharmaceutical or Healthcare Industry required

  • Working knowledge of cGMP regulations

  • In depth knowledge of process, packaging, facility, and cleaning validation

  • Occasional flexibility to work extended weekend and evening hours to achieve results on time and in full

PLEASE NOTE: 3RD PARTIES/SUBCONTRACTORS/SUBCONTRACT AGENCIES ARE NOT ELIGIBLE FOR THIS POSITION. SUBCONTRACT AGENCIES NEED NOT APPLY.

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