Downstream Bioprocess Associate
Tandem Project Management
- Dublin
- Contract
- Full-time
Our client, a biopharmaceutical company in Dublin, is seeking a Downstream Bioprocess Associate to join their team. 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 Biotech facility 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), e.g. EHS metrics, Production Plan, OEE, compliance and team training.
- Execute commercial manufacturing processes according to established work instructions and Standard Operating Procedures.
- Work as part of a dedicated process team where flexibility and teamwork are a key requirement.
- Generate SOPS/Electronic Batch Records for start-up.
- 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/
- 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 requirement shall be deemed equivalent.
- 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.