<p>Piper Companies is seeking a CQV Engineer to join a leading organization focused on ensuring operational readiness for biotech innovators. This role requires strong expertise in aseptic fill lines and the ability to work independently in a fast-paced environment.</p> <p>Key Responsibilities</p> <ul> <li>Develop and maintain user requirement specifications, traceability matrices, and design documentation. </li><li>Author IOQ protocols and assist with PQ planning and execution. </li><li>Conduct ongoing assessments and support integration of test references. </li><li>Collaborate with vendors and cross-functional teams, including QA and process engineering. </li><li>Lead commissioning and qualification activities for aseptic fill lines and associated equipment. </li></ul> <p>Qualifications</p> <ul> <li> <p>Experience:</p> </li><li> <p>5+ years in pharmaceutical manufacturing.</p> </li><li> <p>2+ years working with aseptic fill lines.</p> </li><li> <p>Strong knowledge of manufacturing equipment (e.g., tanks, autoclaves).</p> </li><li> <p>Proven ability to generate and execute protocols with clear documentation.</p> </li><li> <p>Bachelor's degree in engineering, chemistry, or a related discipline.</p> </li></ul> <p>Compensation & Benefits</p> <ul> <li>Salary: $114,000-$124,000 annually. </li><li>Comprehensive benefits package including medical, dental, vision, 401(k), and sick leave (as required by law). </li></ul> <p>Keywords: CQV, aseptic fill lines, IQ/OQ/PQ, GMP, protocol development, commissioning, qualification, validation, cleanroom, vendor coordination, pharmaceutical manufacturing, equipment validation.</p> <p>#LI-ONSITE #LI-GY1</p>