Career
Quality and Validation Engineer

Skills Required

  • Should have up to date knowledge on the validation requirements, practices and procedures.
  • Must possess good technical writing ability.
  • Should have knowledge to study, isometric, P&ID and as built drawings.

Responsibilities

  • Must write validation protocols and reports.
  • Should perform activities relating to validation such as thermal studies, cleaning, equipment and utility validation.
  • In order to execute protocol, they should often interact with the manufacturing sciences and other engineering departments.
  • Write master plans relating to any specified projects and conduct meetings to execute the validation plan.
  • Design and write summaries for regulatory compliances.

Job responsibilities often vary as the validation engineer may be responsible for process validation of biological proceeds, method validation

Qualification

  • A bachelor’s degree in science or biological or pharmaceutical manufacturing.

Experience

  • 1 to 4 years

 

Job Description

  • The scope of work for this role is to provide QA Validation support to validation activities associated with Quality Control (QC) Laboratory instruments
  • The main responsibility is review and approval of validation documentation including specifications, executed protocols, summary reports, deviations, periodic reviews, procedures, and change controls
  • In addition, this role may provide support to the site’s data integrity initiative
  • Successful candidate requires a strong working knowledge of global GMPs with an emphasis on validation lifecycle including computer system validation, 21 CFR Parts 210 and 211, and Part 11, Electronic Records and Electronic Signatures
  • Candidate requires strong interpersonal, oral and written communication skills as there is a high degree of collaboration required between members of QA Validation, Instrument Validation and QC personnel
  • Candidate must be detail oriented as the main job responsibility is review and approval of validation documentation

Job Requirements
Skills:

  • Strong working knowledge of global GMPs with emphasis on validation, including computer validation
  • Strong interpersonal, oral and written skills
  • Detail oriented

 

Education & Experience:

  • Candidate must have at a minimum a BS in biology, engineering or related sciences with at least 3 years of pharmaceutical or biopharmaceutical experience in a quality assurance and/or validation role
Past experience working with QC instrumentation, Labware, Trackwise, and/or Documentum in the pharma/biopharmaceutical field is preferred but not required