Manager Global Inspection Engineer

Zoetis
70d$111,000 - $160,000

About The Position

The Manager Global Inspection Engineer role is a subject matter expert for the visual inspection equipment/process and will perform various duties related to maintaining compliance and the continuous improvement of the visual inspection program. Will support commissioning/qualification activities required to bring automated vision systems into service as well as supporting site operational readiness activities.

Requirements

  • Bachelor's degree in a science related field; Equivalent education and experience may be considered.
  • Relevant advanced degree or training/certificate in manufacturing preferred.
  • Advanced knowledge of Current Good Manufacturing Practices (cGMP), FDA, USP, OSHA, EPA, DEA; other regulatory requirements.
  • Advanced knowledge of Visual inspection principles, practices, and applications.
  • Knowledge of Lean Six Sigma Tools and DMAIC problem solving approaches.
  • Demonstrated excellence in oral and written communication.
  • 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.

Nice To Haves

  • Excellent interpersonal, written and oral communication skills.
  • Strong technical aptitude and ability to train and mentor others.
  • Ability to handle multiple competing priorities.
  • 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.
  • Experience using and/or developing qualification kits and qualifying operators.
  • 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.
  • Direct interaction with Regulatory Agencies during site inspections.
  • 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.
  • Utilize 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.

Benefits

  • Healthcare and insurance benefits beginning on day one.
  • 401K plan with a match and profit-sharing contribution from Zoetis.
  • 4 weeks of vacation.
  • Short-term incentive compensation.
  • Long-term incentives.

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What This Job Offers

Job Type

Full-time

Career Level

Senior

Education Level

Bachelor's degree

Number of Employees

5,001-10,000 employees

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