Validation Engineer III

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      "addressCountry": "United States"
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    "datePosted": "2020-08-19",
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    "description": "<p><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Quality Agents, LLC is a service company offering validation and quality expertise to the pharmaceutical and biotechnology industries.  Our Validation Engineers will be involved with the qualification and requalification of equipment used to manufacture and test biologics/drug product/etc. at client sites.  The Validation Engineer will evaluate the equipment/utility/system/procedures used in development, production, and holding of pharmaceutical products and determine a validation approach.  The individual should have experience with current US and international regulations, guidance, industry best practice in one of the following areas of validation: facilities, utilities, and equipment qualifications, process validation, analytical method validation, or cleaning validation.  The individual will coordinate validation activities with the client and meet timelines.  Documents prepared by the Validation Engineer must be approved by the client.  </span></p>\n<p><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\"> </span></p>\n<p><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Responsibilities include:</span></p>\n<ul>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Interact with clients and works closely with site manufacturing, engineering, and QA to develop validation documents. </span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Travel to various client sites and work independently to complete tasks. </span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Provide qualification and validation services for cGMP manufacturing equipment, systems, and utilities at client sites.</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Exposure to validation aspects of facility start-up, redesign/retrofit, and expansion.</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Writes and executes qualification protocols for a variety of biopharmaceutical equipment and support utilities in accordance with SOPs, master plans, regulatory expectations, and industry standards.</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Conducts temperature mapping studies, including the operation of Kaye dataloggers, or equivalent.</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Review and approve documented test results and maintain records for later analysis.</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Assist with non-conformances, investigations, and troubleshooting of equipment, utilities, and systems.</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Able to read P&amp;IDs, isometric drawings, and As-built drawings.</span></li>\n</ul>\n<p><br></p>\n<p><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Skill Level and Requirements:</span></p>\n<ul>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Ability to problem solve and troubleshoot.</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Technical writing ability and use of Microsoft Word, Excel, Power point, and Project</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Experience with validation equipment such as the Kaye validator, wireless data loggers, or other monitoring devices is strongly desired.</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Experience using statistical tools is a plus to analyze data captured during validation studies. </span></li>\n</ul>\n<p><br></p>\n<p><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Minimum Requirements:</span></p>\n<ul>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">BS in a technical discipline (Engineering, chemistry, microbiology, biology)</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">5 - 7 years of experience in at least one of the following areas:  equipment/utility qualifications, process validation, analytical method validation, or cleaning validation.</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Current driver’s license and auto insurance</span></li>\n</ul>\n<p><br></p>\n<p><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Quality Agents offers a full suite of benefits for full-time employees including:</span></p>\n<ul>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Health, dental and vision insurance</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Life, AD&amp;D and disability Insurance</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Health savings account for participants in our health plan</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">401k retirement plan</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Paid vacation</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Paid sick leave</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Paid holidays</span></li>\n</ul>\n<p><br></p>\n<p><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Quality Agents accepts applications on an on-going basis in order to build a talent pool of potential candidates. These applications remain open for consideration, as positions become available, for one (1) year from the date of application. After that time, or if your application information changes, please submit your application again.</span></p>",
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