Validation Engineer Intern candidate wanted to train on GMP facilities and cGMP requirements. In addition, applicant will be trained on writing technical reports, and Validate Software. Intern will gain hands on experience in all areas of validation. Applicant will be working in a biotech/pharmaceutical environment as a consultant. He/she will be working closely with client's employees on various projects and GMP facilities to help client with validation issues. Applicant must be willing to learn new ideas, techniques and systems. This is an Evergreen Requisition solely used to collect applications. Number of hours per week is flexible based upon school schedule. Assist in preparing and reviewing Validation Life Cycle documentation: Validation Plans, User Requirements Specification, Impact Assessments, Design Specifications, Design Qualification, Installations Qualifications, Operational Qualifications, User Acceptance Testing, Performance Qualifications, Process Validation protocols. Assist in executing validation protocols (DQ, IQ, OQ, UAT, PQ & PVs). Assist in preparing and reviewing Summary Reports. Assist in performing 21 CFR Part 11 assessments required for 21 CFR Part 11 regulations. Assist in preparing and reviewing protocol deviations. Perform system trouble shooting. Ensure all validation documentation is in compliance with Corporate policies, local policies /SOPs and regulatory standards such as Annex 11, Annex 15, 21 CFR Part 11, cGMP, cGAMP, GDP, ICH. Assist in preparing and reviewing validation SOPs and work instructions Collaboration with cross functional teams including; Project Engineers, Project Managers, Quality Representative and Compliance Representative and Operational Representative. Review and modify Standard Operating Procedures (SOPs) Requirements Applicant must be pursuing 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 but not required Knowledge of PC computer OS (typically Windows), knowledge of Word and excel are mandatory. Must have strong written and oral communication skills and organizational skills Possess self-motivation and drive 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. Must be flexible and able to manage multiple priorities simultaneously An Evergreen Requisition is an advertisement for positions that PSC Biotech hires for throughout the year. It is a way for PSC Biotech to build a database of qualified, interested individuals for a particular job function so that when there is a need to fill that type of role, the hiring process will be faster. By applying to an Evergreen Requisition, you are expressing your interest for a particular job function within the PSC Biotech divisions. In addition to submitting your resume to an Evergreen Requisition, we encourage you to continuously visit our Careers website for new opportunities. Please be mindful of the geographic locations you would like to consider. \"PSC Biotech is an equal opportunity employer. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law. Associated topics: biomechanics, biomedical, bioprocessing, hereditary, molecular, neuro, neurodegenerative, nutrition, pathogenesis, therapeutic
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