Validation Intern

Req ID: 16055
Job Category: Engineering

Location: Athlone, Westmeath

Posting Date: July 25, 2019

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Position Summary

The Manufacturing Engineering Intern will be a key member of Athlone Engineering team, and will be based in Athlone. The Manufacturing Engineer will be responsible for the successful execution of projects identified by the Manufacturing Engineering lead through the Athlone site project priority list. These projects will be in several categories, including the following: new process / equipment remediation, process innovation and automation, product transfers / feature enhancement, new material & equipment qualification, process optimisation, continuous improvement (CAPEX & OPEX) / cost reduction in facilities and maintenance.

The Manufacturing Engineer main area of responsibility will be the technical engineering ownership of an aseptic sterile fill finish facility and will provide technical leadership on any process or equipment issues in line with business strategies and objectives. The role will require the manufacturing engineer to understand the user requirements and work closely with vendors to ensure these requirements are incorporated into the equipment, process and facility.

Principal Responsibilities

  • Participate on capital project teams through all phases of projects; these phases will include conceptual design, detailed design, equipment procurement, construction, installation, start up, commissioning, validation, and qualification. 
  • Responsible for initiation and completion of deviations, CAPAs, and change controls for process systems including investigations relating to equipment malfunctions
  • Provide support to Manufacturing and Maintenance as required.
  • Ensure that new process equipment is included in the plant maintenance and calibration program.
  • Plan and manage day-to-day technical support work on process and associated equipment to meet manufacturing or plant shutdown schedules while maintaining a high level of GMP compliance and being cost efficient.
  • Acts as an advocate for continuous improvement activities in the sterile fill finish facility using statistical techniques, lean manufacturing tools, six sigma, design experimentation for process and equipment, FMEA, to achieve targets and cost savings.
  • Ensure the equipment design meets regulatory and user requirement specifications. Act as the client point of contact for all vendor interactions to ensure successful design, testing and equipment delivery to site.
  • Track and report out on projects using standard Alexion templates, ensuring all necessary information is available to key Stakeholders, e.g. Operations, Quality, Validation, Finance and Engineering.
  • Work closely with equipment vendors to ensure a smooth transition between project and operational phases
  • Involvement in equipment system upgrades

Skills

  • IT proficiency, Word & Excel proficiency is strongly desired
  • Ability to work well as part of a team & on own with minimum supervision
  • Good technical capabilities, teamwork abilities and initiative.
  • Strong numeracy skills with focus on attention to detail
  • Strong verbal and written communication skills
  • Excellent academic track record

Education

  • Successful candidate will be undertaking a qualification in pharmaceutical, chemical or mechanical engineering or related engineering field.

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Athlone, Ireland
 

 

Some opportunities happen only once in a lifetime – like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.

 

Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In addition, the company is developing two late-stage therapies, a second complement inhibitor and a copper-binding agent for Wilson disease. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the Forbes list of the World’s Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts’ Innovation District. The company also has offices around the globe and serves patients in more than 50 countries.

 

Alexion’s aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team. Further information about Alexion can be found at: www.alexion.com.