Validation Specialist - Description_______________________________________ _Interphase Systems is a leading management and technology consulting organization that assists clients with planning and managing their business strategy, operations, and investment in technology. We design and implement solutions that drive competitive advantage and manage critical systems to improve business performance. Interphase rewards great performers and encourages employees to be self-starters, working together, providing our customers with outstanding consulting services. We have contract opportunities for proven and professional consultants to work as a Validation Specialists. The selected candidates will bring strong biotech, pharmaceutical or medical device industry expertise and leadership to our emerging Life Sciences group. Our client, a well-established pharmaceutical organization is seeking experienced Computer Systems Validation Engineers with Pharmaceutical/GMP experience to function as a Subject Matter Expert. In this role, the selected candidates will develop all applicable documents for CSV (Computer System Validation) remediation per company standards and work with site engineering, CSV assessors, and auditors to identify, assess, and remediate legacy automation systems. These positions are 24 month contract positions located in Fort Washington, PA and Lancaster, PA. The successful candidates must possess strong experience and passion in the following areas:•Proven experience in computer systems validation (CSV)•FDA Regulations including CFR Parts 210, 211, 11, 820, GAMP and other related Good Practices for Computerized Systems in a GMP environment•ERP system validation experience within the Pharmaceutical industry•Strong knowledge of cGMP's and regulatory compliance issues •Experienced writing and executing validation plans, generating and executing SOPs and protocols, conducting testing, and preparing final summaries •The ability to work as a team player in a consulting environmentAdditional Requirements:•5 years Pharmaceutical Engineering experience specializing in Computer Systems Validation•Strong Technical Writing skills for computer system and manufacturing equipment validations•BS degree in Engineering, Management Information Science, Computer Science, Biology or equivalent•Strong oral and written communication skills a must•Must be a self-starter requiring little supervision•Strong customer service focus a mustA Minimum of 5-7 years of experience is necessary with a proven track record of delivering customer satisfaction. Send resume & cover letter INCLUDING COMPENSATION REQUIREMENTS to
careers@interphasesystems.com. Please Include "Validation Specialist” in the subject line.
www.interphasesystems.com
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Validation Specialist US-Pennsylvania-York/Lancaster
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