RCM Technologies Validation/Qualification Engineer(s) in Rocky Mount, North Carolina
Reference # :17-01046Title :Validation/Qualification Engineer(s)Location :Rocky Mount, NCPosition Type :ContractExperience Level :6 YearsStart Date / End Date :01/22/2018 / 10/26/2018 Description
http://www.rcmt.com/Industries/Life-Sciences.aspxLocation: Rocky Mount, NCJob Title: Validation/Qualification Engineer(s)Start Date: DEC/JAN timeframeOur customeris aleading Global Pharmaceutical CompanyJob Opportunity:Exciting opportunity to be part of a Pharmaceutical Facility expansion Project.MUST have diverse facility, utility, and equipment Qualification and Validation experience.The purpose of these roles is to perform qualification and validation activities for a new facility expansion project. This project includes a large addition to the current structure and activities will included but not be limited to: new filling lines, tanks, utilities, aseptic fillers, autoclaves, parts, washers, sterilizers, transfer panels and multiple other equipment.· Provide services in the areas of qualification, commissioning and validation consultation and guidance to the validation organization on the implementation of compliant cost effective GMP activities.· Provide hands on qualification and validation guidance and support to the site Validation teams on aspects of the qualification and validation cycle as defined by the clients cGMP policies and procedures e.g. SOP's, Validation Plans, Protocol creation and execution( IQ,OQ,PQ), testing strategy, GMP requirements, Test Plans and Validation Summaries including writing and resolving deviations and change controls.· Provides Quality and Validation knowledge, insights and counsel in utilization of Facilities, Utilities and equipment in scope.· Provide full life cycle Authority for specific qualification and validation documentation including, SOP's, protocols, change management, investigations and summaries.· Provide Qualification, Commissioning and Validation expertise as requested to other internal customers.The required skills include but are not limited to experience with 5-10 years validation and qualification in the pharmaceutical or Biotech industry. Strong documentation skills. Writing and executing protocols for facilities, mapping, and qualification of utilities. Experience with sterilizers, parts, washers and aseptic filling lines etcAbout RCM:http://www.rcmt.com/Industries/Life-Sciences.aspxRCM is a recognized national leader in IT and regulatory compliance services providing a broad range of consulting and management services to pharmaceutical, biotech and medical device manufacturers. The unique combination of our IT, Regulatory, and Engineering Practices brings an unparalleled breadth of knowledge and experience to our clients.RCM maintains a dedicated Life Sciences Practice that consistently reevaluates the market to determine areas of improvement. Our practice leaders constantly challenge ourselves to bring "true savings? whether through cost reduction or by reducing a products time to market.We look forward to hearing from you!