Production Engineer

Excellent Production Engineer role in growing pharmaceutical company
Purpose of the role
The Production Engineer will provide technical support to the Production Department to facilitate efficient operations, optimise existing processes, and to ensure that production goals are achieved. The successful candidate will interface with quality and research and development departments to integrate new products or processes into the existing production facility.
Key Responsibilities (include but not limited to):
  • Leads and participates in FMEA’s, investigations, root cause analysis, develops plans and executes tasks to solve process problems including Non Conformances, complaint investigations, Change Control, audit observations and Corrective and Preventive Actions.
  • Analyses the results of testing and determine the acceptability of results against predetermined criteria.
  • Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
  • Lead and participate in cross-functional Continuous Improvement initiatives leading to new or improved production processes, prepare reports, publishes, and makes presentations to communicate findings.
  • Supports the needs of the Production Department in terms of meeting the requirements for quality standards and compliant documentation, capacity, product availability and cost.
  • Provides technical support regarding equipment design and development, testing of materials, preparation of specifications and operator instructions in production operations and implementing new technologies.
  • Participates in the review of current and future procedures, SOP generation, provide training for Production team members.
  • Participates in validation activity, Writes and executes engineering studies and process validation protocols and summary reports (Installation Qualification, Operation Qualification, Performance Qualification, Computer Software Validation and Test Method Validation).
Key Requirements:
  • Bachelor of Science Degree from accredited institution in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related degree.
  • Previous experience working in a regulated industry, such as pharmaceuticals or medical devices is preferred.
  • Six Sigma or Lean Sigma certification or 2 years of experience preferred.
  • Demonstrates strong computer skills, such as the use of Microsoft Office, Minitab, and databases.
  • Ability to oversee multiple projects simultaneously
  • Excellent technical writing skills
  • Outstanding organisational and time-management skills.
  • Exceptional ability to leverage/collaborate effectively with stakeholders.
  • Excellent written and verbal communication and interpersonal skills.
  • Comfortable working in a busy, fast paced regulated manufacturing environment.