Description:
Validation Engineer Intern wanted to train on GMP facilities and cGMP requirements. In addition, applicant will be trained on writing technical reports, the use of Kaye Instruments Digistrip Recorders and Validator Software. Intern will gain hands on experience in all areas of validation.
Applicant will be working in a biotech/pharmaceutical environment as a consultant/contractor for various clients. He/she will be working closely with clients employees on various projects and various GMP facilities to help client with validation issues. Applicant must be willing to learn new ideas, techniques and systems. Applicant must be willing to commute to clients manufacturing sites.
Hours per week: Flexible. We are willing to work around classes.
Salary: Dependent on experience
Responsibilities:
-Writing of Validation Protocols such as IQ, OQ and PQs
-Execution of Validation Protocols such as IQ, OQ and PQs
-Calibration of Thermocouples for Temperature Mapping Studies
-Use of Kaye Digistrip Recorders and Validator Software for Temperature Mapping Studies
-Calculation and interpretation of data for Equipment Validation Studies
-Excel Spreadsheet Generation and Summary Report Writing for PQ studies
-Review and modify Standard Operating Procedures (SOPs)
-Generate test procedures to validate new or previously unvalidated equipment/processes
-Participate in and conduct any or all of the following types of validation:
- Cleaning Validation
- Process Validation
- Computer Validation
- Equipment Validation
- SIP/CIP Validation
- Risk Assessments
Requirements:
Applicant must have graduated with or pursing an engineering or technical degree from a four-year college or university.
Knowledge on regulatory/compliance/validation issues, self-motivated, intelligent and reliable a plus.
Knowledge of PC computer OS (typically Windows), knowledge of Word and excel are mandatory.
Must have strong written and oral communication skills.
Experience in writing technical documents, especially compliance and/or Validation/quality assurance documents and protocols will be desired.
Applicant must also be willing to perform more sophisticated/complicated types of validation work.
Please apply on line only at this link: https://www.psccareers.com/can/applyonline.phpid=52
Location: Austin TX
Compensation: DOE
This is a part-time job.
This is an internship job
Principals only. Recruiters, please dont contact this job poster.
Please, no phone calls about this job!
Please do not contact job poster about other services, products or commercial interests.
