Process Engineer-OSD at Alkermes

Expires in 6 days


Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.

Summary

Support and assist in the manufacture of pharmaceutical products for commercial and clinical supplies. Where applicable, the candidate may be tasked with scale-up and transfer of formulations/processes to the commercial production facility, designing and recommending equipment purchases, and writing/executing qualification/validation protocols. Troubleshooting of automated equipment for pharmaceutical manufacturing, identification and implementation of process/equipment improvements to reduce waste and increase process reliability, and cleaning process development are also within the scope of this position.

Essential Functions

  • Troubleshoot and maintain manufacturing systems, processes and equipment
  • Support development of cleaning processes for the manufacturing area
  • Interface with Tech Transfer in technology transfer of new processes as well as process upgrades to existing technologies
  • "Hands-on" ability to install and troubleshoot instrumentation and equipment
  • Author high quality technical protocols/reports (engineering studies, summary reports, equipment specifications, change controls and investigations)
  • Specify and size manufacturing systems, equipment and process equipment

Required Education and Experience

  • Bachelor of Science in Engineering or related discipline
  • Knowledge of OSD pharmaceutical process and equipment validation
  • Knowledge of cGMP, OSHA, EPA, DEA and FDA facility requirements and regulations
  • Engineering knowledge as it applies to general process systems and equipment

Preferred Education and Experience

  • 0-3 years experience in the pharmaceutical industry

Competencies

  • Excellent communication and documentation skills
  • Excellent organizational skills
  • Ability to self-manage and prioritize workload
  • Ability to react quickly to understand and solve problems
  • Excellent troubleshooting skills
  • Positive attitude

Work Environment

Work will be split between contained manufacturing area and office.

Physical Demands

Ability to lift 25 pounds. Ability to operate all types of production equipment. Ability to wear respiratory protective equipment.

Travel

<10%.
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, color, religion, sex, sexual orientation, gender expression and identity, national origin, ancestry, age, mental and physical disability, genetic information, any veteran status, military status or application for military service, or membership in any other category protected under applicable law.

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