Sr. Manufacturing Process Engineer

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

This Senior Manufacturing Process Engineer position is responsible for compliance with applicable Corporate and Divisional Policies and procedures. Assure compliance with Corporate/Divisional policies and procedures. Provide guidance on building, facilities, utilities, procedural issues, and documentation content and adequacy. Assess manufacturing outages and deviations to determine compliance with specification and procedures. Supports CAPA activities for the GES organization. Support GES compliance and validation programs by reviewing and maintaining records, preparing metrics, and tracking action items. Support Corporate, Division, Regulatory and third party audits.

MAIN RESPONSIBILITIES:
  • Approve changes to facility, utilities and equipment
  • Support CAPA activities for GES organization
  • Interface with auditors - internal, corporate, regulatory or customer
  • Approve Quality records in the Quality System
  • Responsible for completing documentation in a timely manner and in accordance with business needs
  • Independently design and lead complex experiments often with multiple variables
  • Analyze complex problems and identify their impact. Establish probabilities. Draw conclusions reflecting broad business needs.
  • Set complex design and process requirements
  • Responsible for completing documentation in a timely manner and in accordance with business standards
  • Lead and/or participate on cross-functional teams to support organizational goals
  • Understand and comply with applicable EHS policies, procedures, rules and regulations
  • Responsible for implementing and maintaining the effectiveness of the Quality System
  • Other tasks and duties as assigned


EDUCATION/EXPERIENCE REQUIRED:
  • Bachelor's degree (preferably in Engineering, science or a closely related discipline is desired) or equivalent technical experience and demonstrated competence is required
  • 5+ years of significant professional engineering and / or operational experience
  • Minimum of 3 years working knowledge of cGMP regulations and industry documentation standard
  • Experience with audits and approving quality records
  • Strong oral/written communication skills
  • Strong Microsoft Office knowledge base
  • Ability to manage multiple tasks and prioritize accordingly
  • Individual must understand a variety of quality/operational systems that support facility, equipment, utilities and computer systems


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