21338 – Senior Process Engineer Manufacturing Support – Upstream – Limerick Full Time

Purpose: 

This position is technical leadership role within Manufacturing Support, whose major focus is investigating process deviations associated with manufacturing biological products.

Responsibilities: 

• Lead investigations of process related deviations, ensuring they are closed out in a timely, comprehensive and conclusive manner.
• Author, review and approve documentation associated with root cause investigations, along with product impact assessments.
• Provide technical leadership; specifically coaching and mentoring to more junior group members.
• Lead or participate in process and quality risk assessments.
• Drive continuous improvement programs.
• Review and approve manufacturing documentation such as manufacturing records, SOPs and batch sheets.
• Support the site through regulatory audits by providing technical expertise.

Minimum Qualifications and Experience:

• Bachelor, Master, or Doctorate degree in Life Sciences, Biological/Chemical Sciences, or Process/Chemical Engineering.
• A minimum of a BA/BS and a with 8 years relevant experience, MS with 7 years, or PhD with 2 years.
• Experience in biotech industry with good knowledge of manufacturing processes (specifically upstream unit operations) and biological products.
• Knowledge of use and application of variety of problem-solving tools (e.g. Fishbone, Kepner-Tregoe etc.).
• The ability to work effectively in a fast-paced environment with changing priorities and a high level of urgency.
• Strong verbal and written communication skills