Process Engineer - Health and Medical

Trelleborg is a world leader in engineered polymer solutions for almost every industry on the planet. And we are where we are because our talents brought us here. By specializing in the polymer engineering that makes innovation and application possible, Trelleborg works closely with leading industry brands to accelerate their performance, drive their business forward—and along the way, shape the industry and progress that will benefit humankind in the exciting years ahead. Our people are Shaping Industry from the Inside. Why don´t you join us? 

Plats

MLT - Hal Far

Arbetsplats

On-site
Sista ansökningsdag 2024-03-05 Plats: MLT - Hal Far

The Process Engineer follows good manufacturing practices (GMP) and principles to provide engineering support and develop robust manufacturing processes. Has a primary role in the engineering of new, modified and/or existing manufacturing operations in a clean-room environment.

Candidates with 3+ years’ experience in Pharmaceutical / BioPharma or related manufacturing industry will be preferred.

Duties, responsibilities, and authorities:

  • Analyses new product specifications and translates these into manufacturing processes to establish production rates, achieve expected quality levels and establish the reliability of the finished product.
  • Responsible for the completion of the design and development of optimal, cost-effective, and reliable manufacturing processes.
  • Use demonstrated strengths in multiple aspects of medical component and device design and manufacturing capabilities to plan and accomplish goals.
  • Develops process parameters for secondary operations.
  • Conducts data analysis and collaboration with Quality Engineering.
  • Identifies Operational Qualification (OQ) process parameters and Performance Qualification (PQ) settings.
  • Develops and documents standard operating procedures (SOP) and product-specific operating procedures (PSOP).
  • Trains manufacturing personnel on SOPs and PSOPs.
  • Performs DOEs, and participates in the development of control plans, Process Maps, and PFMEA documentation.
  • Collaborates with internal cross-functional teams and corresponding outside vendors needed to meet project needs.
  • Uses standard problem-solving tools, e.g., 8D, 5 Whys, Fishbone.
  • Applies effective inter-departmental communication and escalation.
  • Owns tooling and process from a manufacturability standpoint from development to production release.
  • Partners with the Quality department on investigation and corrective action for any failed First Article Inspection or OQ/PQ
  • Proactively seeks and manages the execution of continuous improvements activities.
  • As an SME, partners with management to establish and develop site-specific processes as required/requested.
  • Lead engineering activities and support day to day operations in the manufacturing area/s.

Continuation of Duties and Responsibilities

  • Participate in "Gemba" walks and stand-up meetings as required.
  • Ensure all Environment, Health and Safety instructions are implemented.
  • Ensure safety performance is adequately communicated
  • Participate in risk reduction plans.
  • Provides mentorship to others through experiences and education as opportunities arise.

Skills/Education:

Required:

  • Degree in Mechanical/Electrical Engineering
  • Ideally 3+ years’ experience in Pharmaceutical / BioPharma or related manufacturing industry

Desired:

  • Master's degree in engineering or any related field.
  • Leadership/Supervisory experience, with decision-making authority/responsibility

Competencies:

  • Ability to read, write, speak, and understand the English and Maltese language.
  • Use of statistical analysis software.
  • Ability to coordinate multiple projects and deadlines, manage and identify the scope.
  • Act as a project leader on major projects.
  • Lean Manufacturing- Proficient in the use of problem-solving tools such as 5 why, Fishbone, 8D, etc.
  • Understanding of manufacturing processes for medical components and devices.
  • Good understanding of metrology principles and methods.

While all personal data will be treated in strict confidence, interested candidates are kindly requested to send their curriculum vitae via email on angela.garas@trelleborg.com

 

Please visit www.trelleborg.com/en/career/welcome  

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