Sr. Validation Engineer
Job Description
Position is responsible for the development and execution of biotechnology computer system validation projects using system life cycle methodology and following project management techniques.
Incumbent will schedule, plan and manage installation, operation and performance qualifications of complex manufacturing computerized systems that control equipment, utilities and facilities. Computerized system validation projects will address new facility construction, new equipment installation, and revalidation of existing control systems.
Detailed understanding of aseptic processing equipment and environments is essential.
Incumbent will assist in facility/system/process improvements, modifications and deviation investigations.
Incumbent will organize and archive validation documentation.
Responsibilities include interpretation and application of regulatory requirements, including 21 CFR Part 11 and industry practices like GAMP, and include presentation of validation packages during regulatory audits.
The incumbent should have strong written skills and is required to write protocols and reports, revalidation strategies, master plans and standard operating procedures.
Work will include execution of protocols including sample collection, analytical testing, data analysis, preparation of reports and presentation of results.
Incumbent will collect and trend computer system performance data, perform statistical analysis and evaluate equipment performance.
Must have excellent technical understanding of manufacturing control systems and processes specific to biotechnology or protein therapeutic production.
Must have a minimum of 3 years of computerized system experience in validation within a pharmaceutical, biotechnology or related field.
Must have knowledge of GMP’s and CFR’s.
Must have strong experience with PLC controllers, and DCS systems.
Experience with Emerson DeltaV, Cimplicity Manager, and Data Historians (OSI/PI) is highly desirable.
Must have excellent written and verbal communication skills.
Applicant should be proficient with standard office software, such as Word, Access, Excel and Power Point.
Familiarity with statistical software preferred.
Good interpersonal skills required.
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