- 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.
- 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
- A bachelor’s degree in science or biological or pharmaceutical manufacturing.
- 1 to 4 years
- 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
- 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