[Remote] Manager Global Inspection Engineer at Zoetis

Ohio, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Bachelor's degree in a science-related field; Equivalent education and experience may be considered
15+ years demonstrated ability in a GMP FDA, cGMP, ISO, or other regulated production environments
At least 3 years previous management or leadership experience including leading or working effectively with a cross-functional group
Advanced knowledge of Current Good Manufacturing Practices (cGMP), FDA, USP, OSHA, EPA, DEA; other regulatory requirements
Advanced knowledge of Visual inspection principals, practices, and applications
Knowledge of Lean Six Sigma Tools and DMAIC problem-solving approaches
Demonstrated excellence in oral and written communication
Solid understanding of basic requirements of regulatory agencies
Previous facility or area start-up experience
Previous experience in operations and engineering
Previous experience with highly automated equipment
Previous experience with combination products, device assembly, pharmaceutical packaging, and filling in aseptic environment
Previous equipment qualification and process validation experience
Previous experience with deviation and change management systems including Veeva

Responsibilities

Partner with Technical Services, Quality, Manufacturing, and Engineering leadership to deliver functionally strong and operationally centered results
Support commissioning/qualification activities required to bring automated vision systems into service as well as supporting site operational readiness activities
Assist in classification of rejected units
Assist with development and evaluation of inspection parameters & techniques for new products, and continued optimization of parameters for existing products
Develop, write, review, and approve SOPs, specifications, and other documents to support the manual/automated visual Inspection, packaging, and AQL sampling
Develop and maintain metrics to measure performance against business objectives and make necessary changes to improve performance
Understand and influence the manufacturing control strategy for automated visual inspection
Actively participate in new equipment and process qualifications
Ensure that the Visual Inspection Program operates to meet the requirements of approved production plans at minimum costs within established quality limits and in accordance with FDA, cGMP, ISO, and OSHA requirements
Assist Engineering, Maintenance, Quality, and Product Development in assuring implementation of robust processes
Utilizes scientific methods and statistical tools to perform investigations, root cause analyses, and impact assessments in support of timely resolution of deviations/discrepancies related to Visual Inspection
Identify corrective and preventive actions (CAPA), lead project to completion within project timelines
Verify effectiveness of CAPA by post-project data collection and analysis
Ability for direct interaction with Regulatory Agencies during site inspections