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Urgent! Process & Utilities Qualification Engineer Job Opening In USA, USA – Now Hiring Stark Pharma Solutions Inc
<p data-end="282" data-start="115"><b>Job Title:</b> Process & Utilities Qualification Engineer<br data-end="173" data-start="170" /> <b>Location:</b> Raleigh, NC (Onsite)<br /> <b>Experience:</b> 5+ Years<br data-end="201" data-start="198" /> <b>Job Type:</b> Contract<br data-end="235" data-start="232" /> <b>Travel:</b> Occasional travel may be required</p> <p data-end="282" data-start="115"><b>Job Overview:</b><br /> <br /> We are seeking Process & Utilities Qualification Engineers at mid-level and senior-level to join our team in Raleigh, NC.
These roles focus on ensuring the successful commissioning and qualification of utilities and process equipment for pharmaceutical manufacturing projects.
Candidates should have experience with Black and Clean utilities, process equipment support, FAT, and proficiency in Kneat software.</p> <p data-end="727" data-start="701"><b>Key Responsibilities</b></p> <p data-end="766" data-start="729"><b>Commissioning and Qualification</b></p> <ul data-end="1239" data-start="767"> <li data-end="926" data-start="767"> <p data-end="926" data-start="769">Lead or support C&Q activities for pharmaceutical utilities and process equipment, ensuring compliance with industry standards and regulatory requirements.</p> </li> <li data-end="1024" data-start="927"> <p data-end="1024" data-start="929">Execute FAT (Factory Acceptance Testing) to validate equipment functionality and performance.</p> </li> <li data-end="1147" data-start="1025"> <p data-end="1147" data-start="1027">Support the qualification of Black and Clean utilities, including water systems, clean steam, HVAC, and gas utilities.</p> </li> <li data-end="1239" data-start="1148"> <p data-end="1239" data-start="1150">Perform process equipment qualification to meet GMP and production readiness standards.</p> </li> </ul> <p data-end="1274" data-start="1241"><b>Documentation and Reporting</b></p> <ul data-end="1560" data-start="1275"> <li data-end="1379" data-start="1275"> <p data-end="1379" data-start="1277">Develop and execute C&Q protocols, including IQ, OQ, and PQ, in alignment with project requirements.</p> </li> <li data-end="1465" data-start="1380"> <p data-end="1465" data-start="1382">Utilize Kneat software to manage, execute, and document qualification activities.</p> </li> <li data-end="1560" data-start="1466"> <p data-end="1560" data-start="1468">Maintain detailed and organized records of all commissioning and qualification activities.</p> </li> </ul> <p data-end="1593" data-start="1562"><b>Collaboration and Support</b></p> <ul data-end="1882" data-start="1594"> <li data-end="1697" data-start="1594"> <p data-end="1697" data-start="1596">Work closely with cross-functional teams, including engineering, validation, and quality assurance.</p> </li> <li data-end="1792" data-start="1698"> <p data-end="1792" data-start="1700">Troubleshoot and resolve issues encountered during commissioning and qualification phases.</p> </li> <li data-end="1882" data-start="1793"> <p data-end="1882" data-start="1795">Ensure all activities adhere to FDA, EMA, and other applicable regulatory guidelines.</p> </li> </ul> <p data-end="1912" data-start="1884"><b>Continuous Improvement</b></p> <ul data-end="2086" data-start="1913"> <li data-end="2013" data-start="1913"> <p data-end="2013" data-start="1915">Identify opportunities to optimize processes and incorporate best practices into C&Q activities.</p> </li> <li data-end="2086" data-start="2014"> <p data-end="2086" data-start="2016">Leverage lessons learned to improve efficiency and project outcomes.</p> </li> </ul> <p data-end="2108" data-start="2088"><b>Qualifications</b></p> <ul data-end="2632" data-start="2109"> <li data-end="2181" data-start="2109"> <p data-end="2181" data-start="2111">Bachelor's degree in Engineering, Life Sciences, or a related field.</p> </li> <li data-end="2284" data-start="2182"> <p data-end="2284" data-start="2184">Proven experience in commissioning and qualification in the pharmaceutical manufacturing industry.</p> </li> <li data-end="2356" data-start="2285"> <p data-end="2356" data-start="2287">Expertise in Black and Clean utilities, process equipment, and FAT.</p> </li> <li data-end="2410" data-start="2357"> <p data-end="2410" data-start="2359">Proficiency in Kneat software for C&Q activities.</p> </li> <li data-end="2483" data-start="2411"> <p data-end="2483" data-start="2413">Strong understanding of GMP, FDA, and other regulatory requirements.</p> </li> <li data-end="2556" data-start="2484"> <p data-end="2556" data-start="2486">Excellent problem-solving, organizational, and communication skills.</p> </li> <li data-end="2632" data-start="2557"> <p data-end="2632" data-start="2559">Ability to work effectively in a fast-paced, team-oriented environment.</p> </li> </ul>
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Unlock Your Process Utilities Potential: Insight & Career Growth Guide
Real-time Process Utilities Jobs Trends in United States, United States (Graphical Representation)
Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph below. This graph displays the job market trends for Process Utilities in United States, United States using a bar chart to represent the number of jobs available and a trend line to illustrate the trend over time. Specifically, the graph shows 10038 jobs in United States and 103 jobs in United States. This comprehensive analysis highlights market share and opportunities for professionals in Process Utilities roles. These dynamic trends provide a better understanding of the job market landscape in these regions.
Great news! Stark Pharma Solutions Inc is currently hiring and seeking a Process & Utilities Qualification Engineer to join their team. Feel free to download the job details.
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An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at Stark Pharma Solutions Inc adheres to the cultural norms as outlined by Expertini.
The fundamental ethical values are:The average salary range for a Process & Utilities Qualification Engineer Jobs United States varies, but the pay scale is rated "Standard" in United States. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.
Key qualifications for Process & Utilities Qualification Engineer typically include Engineers and a list of qualifications and expertise as mentioned in the job specification. Be sure to check the specific job listing for detailed requirements and qualifications.
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