Downstream Bioprocess Associate (Shift)

Summary:
Our client, a biopharmaceutical company in Dublin, is looking for a Downstream Bioprocess Associate. The ideal candidate will be working with the manufacturing operations group, the project design team, the CQV team and the Automation/CSV reps to facilitate the development and validation of the Biotech manufacturing facility.

Responsibilities:

• Support Equipment Design/ HAZOP and Room programming reviews as per requirements.
• Support Operations team to consistently deliver on specific area Key Performance Indicators (KPIs).
• Execute commercial manufacturing processes according to established work instructions and Standard Operating Procedures (SOPs).
• Generate SOPs/Electronic Batch Records for start-up.
• Adhere to Right First-Time principals.
• Escalate issues as appropriate to Process Lead.
• Maintain a high level of personal expertise and working knowledge of all aspects of the manufacturing process and process equipment through continuous training and development.
• Liaise with other groups and individuals to ensure planning of tasks is effective and linked into the manufacturing process plan.

Qualifications & Experience:

• Minimum of a Level 7 qualification in a science or engineering discipline or a level 6 with a minimum of 3 years’ experience in a GMP Manufacturing.
• Knowledge of applying Lean Six Sigma and Lean methodologies in a workplace environment.
• Experience in a highly regulated pharmaceutical manufacturing environment is desirable.
• Start-up experience in a large-scale commercial drug substance facility desirable but not essential.
• Good understanding of Upstream/Downstream Processing and experience an advantage.