Senior Manufacturing Technology Engineer

Manufacturing/Ops

icon-location-marker Cruiserath - IE
Posted 24 days ago Full_time R1517833

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

 

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Bristol-Myers Squibb has built a new state-of-the-art Multi-Product Cell Culture (MPCC) biologics manufacturing facility in Ireland, Cruiserath, Dublin 15 - a $1 billion investment. This new facility will significantly increase Bristol-Myers Squibb’s biologics manufacturing capacity and play a central role in its global manufacturing network.

BMS Cruiserath Biologics is seeking to recruit a permanent Senior Manufacturing Technology Engineer as part of Manufacturing Sciences and Technology. The Manufacturing Technology group are responsible for process validation and continued process technical support to cell culture, primary recovery, purification and ultrafiltration/diafiltration unit operations for the commercial manufacture of mammalian cell processes in the Multi Product Cell Culture facility. The successful candidate will be key contributor to a dynamic and highly technical global team. This position will build collaborations with Manufacturing, Engineering, Quality Assurance, Quality Control and Global Regulatory Sciences groups.

Key Duties and Responsibilities:

  • Act as technical transfer, process validation and compliance SME within the Manufacturing Technology group.
  • Drive continuous quality improvement efforts in the area of process validation and CMC documentation for regulatory filing for the Cruiserath Multi Product Cell Culture facility.
  • Provide expert review of technical transfer protocols and reports as well as executed batch records, executed study protocols and associated documentation.
  • Author and /or review CMC documentation for regulatory submissions and support responses to health authority queries.
  • Act as compliance SME reviewer for process investigations and study protocol deviations, CAPAs, process improvements and change controls.
  • Responsible for maintaining current standards of cGMP compliance, BMS corporate, site and regulatory agency requirements.
  • Act as leader for cell teams within the Manufacturing Technology group focussed on delivery of process technical transfer and validation.

Qualifications, Knowledge and Skills Required:

  • Minimum BSc or equivalent with at least 4 years’ experience in technical transfer, process validation and cell culture manufacturing technical support in the biopharmaceutical industry.
  • You have demonstrated awareness of cGMP compliance and regulatory agency requirements as well as practical experience with filing submissions and health authority audits.
  • Continuous improvement mindset with operational excellence certification an advantage.
  • People leadership skills, including coordinating multi-disciplinary teams and balancing competing priorities such as project assignments.
  • Strong oral communication and technical writing skills verbal & written communications skills.

Please note that this role may require periods of extended hours or a modified work schedule and may require on-call availability

Employees are expected to display the BMS Biopharma Behaviours, which enable them to be successful and perform at their highest level:

Passion: We pursue excellence to help patients prevail.

Innovation: We embrace new ideas.

Accountability: We own our outcomes and the outcomes of others.

Speed: We act with urgency and agility.

Why should you apply:

  • You will help patients in their fight against serious diseases

  • You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.

  • You’ll get a very competitive salary and a great benefits package including an annual bonus, pension contribution, health allowance, 26.5 days annual leave, life insurance, on site gym and gain-sharing bonus.

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.