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Validation & Engineering Group, Inc. · 2 months ago

ATL01-111025_ Packaging Validation Engineer_PA

Allentown, PA

Full-time

Onsite

Senior Level

5+ years exp

Validation & Engineering Group, Inc. (V&EG) is a leading technical services provider specializing in high-quality Commissioning & Qualification, Validation, Compliance, Quality Assurance, and Engineering services for the Biotechnology, Pharmaceutical, Advanced Therapies, Medical Device, and Chemical (API) industries. The company is seeking a Packaging Validation Engineer to focus on the qualification of packaging equipment and processes, ensuring compliance with regulatory requirements and supporting continuous improvement initiatives.

BiotechnologyConsultingProfessional ServicesQuality Assurance

Responsibilities

Lead and execute equipment and process qualification activities (IQ/OQ/PQ) for primary and secondary packaging systems, including serialization/aggregation systems

Prepare and execute validation protocols and reports, ensuring adherence to cGMP, FDA, and EU regulatory expectations

Support packaging validation life-cycle documentation, including URS, FRS, DS, FAT, SAT, risk assessments, and traceability matrices

Participate in deviations, CAPAs, and change control processes related to packaging systems and associated utilities

Collaborate with Production, Engineering, and Quality to troubleshoot equipment and process issues during qualification and routine operations

Support technology transfer activities and new product introductions related to packaging operations

Coordinate multiple project tasks from inception to completion, applying sound project management and documentation practices

Ensure compliance with GMPs, Good Engineering Practices (GEP), and company standards and procedures

Qualification

Pharmaceutical packaging systemsEquipment qualificationValidation principlesSerialization systemsTechnical documentationAnalytical skillsOrganizational skillsTechnical writingCommunication skills