- A fantastic opportunity has arisen for a Downstream Bioprocess Associate to join our client’s biopharmaceutical facility in Co. Dublin.
- The successful candidate will 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.
Core Duties and 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), 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
- 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.
Minimum Qualifications and Experience:
- Minimum of a Level 7 qualification in a science or engineering discipline.
- A level 6 with a minimum of 3 years’ experience in a GMP Manufacturing requirement shall be deemed equivalent.
- Demonstrated successes in a team environment, such as project teams, Lean Six Sigma team, etc.
- Demonstrated problem solving capabilities.
- 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.
- Ability to interact with multiple stakeholders across numerous departments
- Excellent communication skills and the ability to work in a cross functional collaborative environment.
- Good interpersonal skills, attentiveness, and an approachable manner for interactions with inter departmental colleagues.
- High degree of problem-solving ability and adherence to scheduled timelines
To Apply: Quote – PE22106
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
14 Danville Business Park, Kilkenny, Ireland
+353 56 77 90100
Please note, we do not require agency assistance with this role.