Bioprocess Associate

My client is a Bioprocess Associate for a contract opportunity. You will be responsible for all procedures and processes associated with the Manufacture of Commercial Large-Scale Drug Substance at the manufacturing facility. The Bioprocess Associate 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).

The role:

• 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.
• Support Operations team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g., EHS metrics, Production Plan, OEE, compliance and team training.
• Execute commercial manufacturing processes according to established work instructions and
• Standard Operating Procedures.
• Generate SOPS/Electronic Batch Records.
• Adhere to Right First-Time principals.
• Provide assistance and/or support maintenance, engineering, quality or other colleagues as requested.
• 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

Key Attributes

• Ability to work cross functionally and with multiple stakeholders.
• Troubleshooting capabilities.
• Understanding of Drug Substance Manufacturing Operations.
• Understanding of GMP requirements in a Bio-pharmaceutical Facility.
• Excellent communication skills.
• Ability to multitask.

Qualifications/ Education

• Level 7 qualification in a science or engineering discipline.
• Or a level 6 with a minimum of 3 years' experience in a GMP Manufacturing requirement shall be deemed equivalent.

The Next Step for you: Should this position be of interest to you please forward your CV to Barry O'Mahony from Next Generation Recruitment or alternatively call on the main line on 016629120 Next Generation are specialists in Supply Chain, Procurement, Engineering, Quality, Technical and Operation (permanent, contract and temporary) positions. Applications are in strict confidence. Next Generation will never share your data outside of our organisation without your prior written consent. Please read our Data Protection Policy on our website.