Quality Assurance Engineer

Overview: TekWissen group is a workforce management provider throughout the USA and many other countries in the world. Our client is a leading biotechnology company that combines technological expertise with world-class manufacturing and scientific insight to support the delivery of innovative medicines for a wide range of diseases. Specializing in pharmaceutical ingredients, bioscience, biopharmaceuticals, custom manufacturing, and cell and gene therapy, the company provides comprehensive services across the pharmaceutical, biotech, and life sciences sectors. It supports every stage of drug development, from early research to commercial production, and offers solutions in biologics, small molecules, and specialty ingredients. Committed to quality and innovation, the company serves as a critical partner in advancing therapeutic solutions and streamlining complex manufacturing processes, with a global presence that ensures access to scalable, flexible, and compliant technical expertise. Job Title: Quality Assurance Engineer Location: Tampa, FL - 33634 Duration: 12 months Job Type: Temporary Position Work Type: Onsite Summary The QA Engineer is responsible for ensuring the timely development, review, and approval of engineering, validation, and lifecycle documentation in compliance with corporate procedures, SOPs, cGMP standards, and industry best practices. This role supports validation activities across the full lifecycle and ensures the facility remains inspection-ready and compliant. Work Model: 100% On-site. Responsibilities: Review and approve engineering and validation documentation, including IQ, OQ, PQ, and PPQ protocols, validation master plans, risk assessments, calibration, and periodic reviews. Collaborate with plant and external engineering teams to ensure new installations, systems, and commissioning documentation comply with cGMP requirements. Support the full Validation Lifecycle from design through operational improvements and revalidation programs. Represent QA in cross-functional teams supporting production facility build-outs and laboratory move activities (commissioning, validation, CSV). Create, review, and approve SOPs, Change Controls, CAPAs, deviations, forms, reports, and other quality system documentation. Partner with internal and external stakeholders to provide quality validation support aligned with project and regulatory requirements. Interface with Manufacturing, Packaging, Engineering, MSAT, PD, and QA/QC teams to resolve process issues and implement changes. Conduct risk identification and management throughout the product lifecycle using risk management tools. Support deviation investigations related to manufacturing equipment, utilities, automation, computer systems, validation, and laboratory instruments. Contribute to continuous improvement initiatives within GMP Validation and Change Control programs. Participate in internal, client, and regulatory audits. Ensure the site maintains cGMP compliance and inspection readiness. Establish, maintain, trend, and report Quality KPIs and metrics. Participate in Management Review, Quality Review Board, Deviation Review Board, and Change Review Board meetings. Perform additional duties as assigned by the Senior Manager of QA Operations. Required Qualifications Strong knowledge of cGMP regulations and compliance requirements. Hands-on experience with validation processes (IQ, OQ, PQ, PPQ). Experience reviewing and approving validation and engineering documentation. Proficiency in Change Control, CAPA, Deviations, and Quality Systems documentation. Understanding of Validation Lifecycle and revalidation processes. Experience supporting audits (internal, client, regulatory). Risk management knowledge and application in GMP environments. Cross-functional collaboration and stakeholder management skills. Strong analytical, documentation, and problem-solving skills. Experience supporting facility start-up, commissioning, or laboratory relocations. Exposure to computerized system validation (CSV). Experience in biologics, pharmaceutical, or medical device manufacturing environments. Knowledge of KPI tracking, trending, and quality metrics reporting. Continuous improvement mindset and experience in quality system enhancement initiatives. TekWissen® Group is an equal opportunity employer supporting workforce diversity.

Created: 2026-03-10