Validation Technician

TjoapackClinton, TN
26dOnsite

About The Position

The Validation Technician supports the Engineering / Technical Services team by developing and executing validation and qualification activities for primary and secondary pharmaceutical packaging processes and equipment. This is a hands-on, execution-focused role responsible for supporting qualification protocols, technical documentation, and packaging specifications. The Validation Technician works closely with Engineering, Quality, Production, and Customer teams to ensure equipment, processes, and documentation meet GMP and customer requirements.

Requirements

  • 1–3 years of experience supporting validation, packaging, or manufacturing activities in a regulated environment
  • Understanding of basic cGMP requirements or ability to complete pharma safety training
  • Strong technical writing skills
  • Experience evaluating packaging components; TOPs experience preferred
  • Familiarity with manufacturing operations and production support
  • Ability to manage multiple tasks, meet timelines, and work effectively under pressure
  • Excellent verbal and written communication skills
  • Proficient in Microsoft Office 365 (Word, Excel) and Microsoft Teams

Responsibilities

  • PROCESS & EQUIPMENT VALIDATION: Develop and support execution of qualification protocols including FAT, SAT, Engineering Studies (ES), IQ, OQ, and PQ. Support validation activities to ensure equipment and processes meet GMP and customer requirements
  • PACKAGING SPECIFICATION & COMPONENT EVALUATION: Perform technical evaluations of packaging components and processes. Identify and assess the impact of changes on packaging and serialization processes
  • TECHNICAL DOCUMENTATION DEVELOPMENT: Review, and maintain Master Batch Records (MBRs). Develop Manual Master Setup Sheets and Work Instructions supporting batch records and technical processes. Prepare Label Requests and verify accuracy, traceability, and correctness. Ensure documentation supports validated and efficient production processes
  • PROJECT & CHANGE SUPPORT: Participate in projects supporting equipment, process, or documentation changes. Collaborate with cross-functional teams to support implementation of approved changes. Assist with training activities related to new methods or technologies
  • CONTINUOUS IMPROVEMENT: Identify inefficiencies in validation or documentation processes. Support Root Cause Analysis (RCA), Change Control (CC), CAPA, Risk Assessments (RA), and validation activities in accordance with Tjoapack procedures
  • COMMUNICATION & COLLABORATION: Collaborate with Engineering, Quality, Production, and Customer teams. Participate in team meetings and contribute to a positive and proactive team environment

Benefits

  • Gain hands-on experience in validation and technical services within a regulated pharmaceutical environment
  • Work cross-functionally with Engineering, Quality, and Production teams
  • Be part of a global organization focused on patient safety and supply chain reliability
  • Opportunities for learning and professional growth
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