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Group: JOBS 2.0: Job Search Career Networking Staffing. Post Resume -Get Paid by Employers at Resumark .com Subject: Robert Ciociola posted a job: "Hiring a Process Validation Scientist 402 in Lancaster, PA Process Validation Scientist - Lancaster, PA 402 Contract position-15 months send resumes to: bciociola@covexllc.com . The scientist will work with Operations (Team Leaders, Operators and Technicians) and Planning to identify the needs of the business, in order to define the processes to be validated. The defined processes will be incorporated into protocols and reports that fulfill the requirements identified by the Quality unit. Finally, execution of the protocols must be closely managed to coordinate the activities of the Operations team and Laboratory personnel so that they executed with minimal impact to compliance commitments, production schedules, and project objectives. The scientist will also provide appropriate training to all impacted areas in order to ensure that the project execution and ongoing production activities are executed and maintained in a state of compliance. The Process Validation Scientist will lead the remediation projects including but not limited to 1) project scheduling 2) understanding and leading change control 3) training 4) sample collection and accountability 5) coordination with Engineering to complete any associated cleaning validation or qualification activities 6) coordinating with planning to make product available to the market according to the timeline 7) performing statistical data analyses as appropriate to demonstrate reproducibility of the process 8) recommending post-validation monitoring requirements and writing and executing post-validation monitoring plans and reports 9)acting as the SME for any audits of the documentation generated 10) participating in execution and support of the ongoing process verification activities at the site. The focus of this role will be the execution of the site's validation master plan of which the specific responsibilities will be shared amongst other key positions in Operations, Planning, Quality, Engineering and R&D. The responsibilities include, but are not limited to, 1) participate in the writing and execution of the site validation master plan 2) develop and execute process validation maintenance program 3) ensure manufacturing processes are in compliance with cGMPs 4) ensure manufacturing processes are in compliance with environmental as well as OSHA & J&J safety regulations 5) effective management of owned items on the site compliance dashboards 6) partner with Operations, Engineering and Quality to resolve non-conformances occurring during any of the process validation related activities 7) investigate any process validation items elevated to CAPA as a result of the validation 8) implement cGMP process improvements, 9) support other business objectives including safety, reliability and line extensions by incorporating them into the validation plans if possible. Education: A minimum of a Bachelors degree is required. A focused degree in chemistry, microbiology, or science discipline is preferred. A minimum of 3 year experience in process ... http://bull.hn/l/TB49/3"

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