Kasmo global

Job Summary:We are looking for a proactive and detail-oriented Validation Engineer to join our pharmaceutical manufacturing team. The successful candidate will be responsible for planning, executing, and documenting validation activities to ensure compliance with GMP regulations and global regulatory standards (FDA, EMA, WHO, etc.). This role is critical to maintaining product quality, patient safety, and regulatory readiness.Key Responsibilities:<ul><li>Develop and execute validation lifecycle documentation including Validation Master Plan (VMP), User Requirement Specification (URS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).</li><li>Perform equipment qualification for manufacturing, packaging, and laboratory systems.</li><li>Conduct process validation, cleaning validation, and utility qualification (e.g., WFI, HVAC, Compressed Air, Pure Steam).</li><li>Support Computer System Validation (CSV) activities in alignment with GAMP 5 and 21 CFR Part 11 (if applicable).</li><li>Prepare and maintain validation protocols, summary reports, and deviation/change control documentation.</li><li>Ensure compliance with GMP, ICH Q7-Q10, WHO TRS, and relevant local/international regulations.</li><li>Assist in regulatory inspections and audits by presenting validation data and documentation.</li><li>Collaborate with cross-functional teams: Quality, Production, Engineering, IT, and R&amp;D.</li><li>Participate in continuous improvement projects related to validation efficiency and compliance.</li></ul>Qualifications:<ul><li>Bachelor&rsquo;s or Master&rsquo;s degree in Pharmaceutical Sciences, Chemical Engineering, Mechanical Engineering, or related field.</li><li>2&ndash;6 years of experience in validation within the pharmaceutical or biopharmaceutical manufacturing industry.</li><li>Strong knowledge of GMP regulations, validation methodologies, and regulatory expectations.</li><li>Experience in preparing and executing validation documentation.</li><li>Exposure to regulatory audits (USFDA, EU, WHO, MHRA, etc.) is desirable.</li><li>Excellent documentation, analytical, and communication skills.</li><li>Proficient in MS Office and documentation management systems.</li></ul>Preferred Skills / Certifications:<ul><li>Knowledge or certification in Six Sigma, Lean, GAMP 5, or QRM (Quality Risk Management).</li><li>Experience with equipment lifecycle management and change control systems.</li><li>Familiarity with electronic quality management systems (eQMS) and digital validation tools.</li></ul>Job Types: Full-time, ContractBenefits:<ul><li>Health insurance</li></ul>Schedule:<ul><li>8 hour shift</li></ul>Ability to Commute:<ul><li>Plano, IA 52581 (Required)</li></ul>Ability to Relocate:<ul><li>Plano, IA 52581: Relocate before starting work (Required)</li></ul>Work Location: In person <div id='job-id'>Job Id: x2/lP3SOVYhHBvgDL4ty8JB2OVaxhPvDfp+E1fwl7xOz9odDPMwClHXqh59rk0NAYbEyklhvUNKLvgBVsTvFw+mtXyjdOitn4mFjAa9p5omY9RYV82hkHW6b</div>

Validation Engineer

Join Kasmo global and explore exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Test Engineer

Validation Scientist (Media Fills, Smoke Profile, AVS, EMPQ)

Validation Engineer

Test and Evaluation Engineer

TECHNICAL OPERATIONS MANAGER

Principal Verification Engineer

PE Verification Engineering