Process Engineer

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    "datePosted": "2025-05-14",
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    "description": "<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">Quality Agents, LLC offers validation and quality expertise to the pharmaceutical and biotechnology industries. </span><br><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">We are seeking a detail-oriented and collaborative Process Engineer to support manufacturing and technical operations in a dynamic biotech environment. This role plays a key part in optimizing existing processes, implementing new technologies, and ensuring consistent, compliant production of clinical and commercial biologics.</span><br><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">The ideal candidate brings hands-on experience in biotech or pharmaceutical process engineering, with a focus on upstream, downstream or cell therapy operations.</span></p>\n<p><br><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt; font-weight: bold;\">Key Responsibilities</span><br></p>\n<p><br></p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">•    Support the design, scale-up, optimization, and validation of biopharmaceutical manufacturing processes.</span><br><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">•    Assist in tech transfer activities for new products or process changes.</span><br><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">•    Develop and revise process documentation including batch records, SOPs, and protocols.</span><br><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">•    Investigate and troubleshoot process deviations, equipment issues, and production challenges.</span><br><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">•    Analyze process data and identify opportunities for improvement in yield, efficiency, or quality.</span><br><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">•    Collaborate cross-functionally with QA, QC, Manufacturing, and Engineering teams.</span><br><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">•    Support commissioning, qualification (IQ/OQ/PQ), and validation activities for equipment and systems.</span><br><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">•    Ensure all work aligns with GMP and regulatory requirements. </span></p>\n<p><br></p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt; font-weight: bold;\">Minimum Requirements:</span><br></p>\n<p><br></p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">•    B.S. or M.S. in Chemical Engineering, Biochemical Engineering, or related field.</span><br><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">•    3+ years of experience in a biotech, pharmaceutical, or GMP-regulated environment.</span><br><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">•    Familiarity with upstream (cell culture/fermentation) or downstream (purification) processes.</span><br><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">•    Experience with process monitoring, root cause analysis, and continuous improvement initiatives.</span><br><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">•    Working knowledge of industry guidelines (GMP, ICH, FDA).</span><br><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">•    Strong communication, organization, and problem-solving skills.</span><br></p>\n<p><br></p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">Quality Agents offers a full suite of benefits for full-time employees including:</span><br><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">•    Health, dental and vision insurance</span><br><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">•    Life, AD&amp;D and Disability Insurance</span><br><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">•    Health savings account for participants in our health plan</span><br><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">•    401k retirement plan</span><br><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">•    Paid time off</span><br><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">•    Paid holidays</span></p>\n<p><br></p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">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><br></p>",
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