Validation Engineer

Role: Validation EngineerLocation: South Carolina Duration: 9+ Months (Possible Extension) Job Description:We are seeking experienced Validation Engineers to support an onsite pharmaceutical manufacturing project in South Carolina. This role will focus on validation execution, equipment qualification, gap assessments, mixing studies, smoke studies, aseptic processing validation, and instrument/equipment qualification activities.The project is driven by audit findings and validation gaps within the site’s existing validation program. Candidates should have strong hands-on validation experience and be comfortable driving execution activities in a fast-paced manufacturing environment.Responsibilities:Execute validation activities for pharmaceutical manufacturing equipment and systems Perform validation gap assessments and review qualification packages Evaluate existing IOQ/OQ documentation and identify gaps between OQ and PQ requirements Support equipment qualification activities related to tanks, filling systems, and manufacturing equipment Support mixing studies including tank qualification, viscosity evaluation, matrix/bracketing approaches, and risk assessments Assist with smoke study execution in aseptic processing environments Support validation activities involving tunnels and lyophilizers Execute protocols and maintain validation documentation Identify validation gaps and recommend mitigation strategies Support audit remediation and validation compliance activities Coordinate with cross-functional teams to ensure project timelines are met Required Qualifications:Validation execution experience in pharmaceutical, biotech, or aseptic manufacturing environments Strong equipment qualification experience Strong understanding of IQ/OQ/PQ lifecycle requirements Experience performing validation gap assessments Tank qualification experience Mixing study experience or knowledge of equipment-based mixing qualification Aseptic processing experience Smoke study execution experience or understanding of smoke study practices Experience supporting protocol execution and documentation Ability to assess qualification package robustness and compliance readiness Strong communication and problem-solving skills Ability to independently drive work and manage challenging stakeholders Education:Bachelor’s degree in Engineering, Science, Life Sciences, or related technical field preferred Equivalent hands-on validation experience will also be considered