Validation Specialist V - OQSIE
Swiftwater, PA 18370
About the Job
The Validation Specialist will be responsible for generating development / validation protocols and reports, compiling data packs and analyzing data for adherence to established acceptance criteria. Typical processes being developed / validated include mixing, filling, formulation, visual inspection and lyophilization, . Studies supporting these processes include hold time, CCIT, stability, Part 4 compliance. Experience Requirements:
Experience: 5 to 7 years. Experience in, Process Validation (formulation, filling, visual inspection and/or lyophilization),Performance Qualification, E&L, CCIT and Part 4 compliance Familiar with Extractables/Leachables. | |||
| Skills: | Skills, MS Office 2010, E Doc, Pharmaceutical Validation, Bio Pharma Validation, Validation execution, Technical writing abilities and good time management. Strong root cause analysis skills with cGMP experience. To be able to establish working relationships with other support and production areas in order to gather all of the necessary information required. Must be proficient in E Doc with a working knowledge of templates, workflows and approval process Proficient in MS Word, Excel, Powerpoint and Outlook Interact well with a diverse group of individuals Self-motivated and willing to be proactive in resolving issues Excellent Verbal and written communication skills. Ability to work in a team environment. | ||
| Education: | BS/MS in Engineering, Life Science or Physical Science | ||
Source : OQSIE