Process Validation Scientist I
This individual is responsible for execution of Process Validation (PV) studies or associated PV support with intensive supervisory direction.
The individual performs assigned duties according to specified procedures and receives detailed instructions. The individual performs a variety of routine work within established policies and procedures, and receives detailed instructions on new projects and assignments.
Able to work with intensive assistance and supervision on 1 to 3 types of module tasks concurrently.
The individual is expected to be a subject matter expert for routine assignments and it is expected that questions on tasks or issues will be raised by this individual when clarification or greater technical expertise is required.
Bachelor of Science Degree in Chemical Engineering, Mechanical, Biology, Biochemistry are preferred. Other life science degrees are acceptable.
0-3 years of biotech industry experience in process validation, process development, or manufacturing.
Licenses or Certifications
Familiarity with large scale manufacturing and current Good Manufacturing Practices.
Good communication, technical writing, organizational and interpersonal skills; Good computer skills (including Word, Excel, Outlook and PowerPoint.)
Able to perform elementary data analysis e.g. simple graphing, charting, predefined calculations, e.g. mean, std. deviation , SPEW, MAD.
Technical writing skills are critical. The ability to write technical documentations clearly and concisely is an absolute requirement. This position will define and execute methods of process validation for different projects under supervision of higher level PV scientists/ project leaders/ managers which will be scrutinized by regulatory bodies and customers.
Qualities & Attitude
Communicates well with all members of the team.
Able to clearly express ideas and point of view both verbally and in writing. Has good interpersonal skills. Shows commitment and dedication and strives to be ahead of schedule. Practices safety awareness at all times and considers impact of actions prior to executing activities.
This person may represent PV in ad hoc meetings. This person must therefore not only follow direction, but also assimilate information during preparation phases of a project to gain a clear understanding of the rationale behind methodologies and requirements. Must be able to communicate and defend to others the requirements to follow or the selection of applied methodologies as provided by immediate supervisor.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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