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API Manufacturing Engineer

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Sligo, SO

  1. Operations
  2. Manufacturing Process
  1. Full-time
R00108985

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on XFacebookInstagramYouTube and LinkedIn


Job Description

We are looking for an API Manufacturing Engineer to join our team in Manorhamilton Road, Sligo.  This is a fixed term contract for 24 months. This position reports to the API Operational Leader. As an API Manufacturing Engineer, you will assist in ensuring compliance with all safety, regulatory, operational and organisational requirements.

Roles and Responsibilities

  • Monitoring and troubleshooting of the manufacturing process and equipment issues and process optimization.
  • Developing supporting documentation, SOPs, PFMEA, Control Plans, and work instructions compliant with GMP.
  • Support New Process Introductions processes.
  • Document/Procedure and Process Streamlining/updates.
  • Support and implement compliance initiatives.
  • Support regulatory or other inspections/audits.
  • Develop inter-departmental communication & planning
  • Measure and track Department metrics
  • Support New Process Introductions processes.
  • Adhere to and support all EHS & E standards, procedures and policies.
  • Champion Operational Excellence (OpEx) within the department to drive a culture of continuous improvement
  • Ensure department is maintaining implemented processes and tools: e.g. 6S, Tier boards.
  • Attend monthly (or quarterly) OpEx governance meeting for their department (department senior manager and OpEx manager) to discuss progress and identify opportunities for future improvement
  • Act as an interim Technical Shift Leader (TSL) when required.

Qualifications

  • Degree in science or engineering.
  • Minimum of 3 years’ experience in Batch processing operations in an FDA/ HPRA regulated industry.
  • Strong knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is essential.

Closing Date for applications is the 15th July


Additional Information

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.