Bioprocess Associate (Shift)

Summary:

Our client, a biopharmaceutical company in Dublin, is looking for a Bioprocess Associate. The ideal candidate will be responsible for the preparation, operation and monitoring of equipment, use of business systems and carrying out tasks including but not limited to the cleaning, validation, in-process testing and basic maintenance of equipment in accordance with current Good Manufacturing Practices (cGMPs).

Responsibilities:

• Work with the manufacturing operations group, project design team, the CQV team, the Automation/CSV reps to facilitate the development and validation of the manufacturing facility.
• 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 principles.
• Escalate issues as appropriate to Process Lead.
• 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.
• Understanding of Drug Substance Manufacturing Operations.
• Understanding of GMP requirements in a Bio-pharmaceutical Facility.