Bioprocess Associate

  • Location:

    Dublin North, Dublin

  • Sector:

    Quality

  • Job type:

    Temporary

  • Salary:

    Negotiable

  • Job ref:

    BBBH2406_1592414066

  • Published:

    26 days ago

The Bioprocess Associate is responsible for all procedures and processes associated with the Manufacture of Commercial Large-Scale Drug Substance.
You 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). You will operate to the highest standards of Safety, Quality and Compliance.

Responsibilities:
* Work with the manufacturing operations group, project design team, the CQV team, the Automation/CSV reps to facilitate the development and validation of our Clients 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
* 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 and Experience:

General
* Demonstrated successes in a team environment in either a project or work related activities.
* Demonstrated troubleshooting competency.

Technical
* Broad Understanding of Drug Substance Manufacturing Operations is desirable.
* Good understanding of GMP requirements in a Biopharmaceutical Facility.

People
* Ability to interact with multiple stakeholders across numerous departments
* Excellent communication skills and the ability to work in a cross functional collaborative environment.
* Good "Can do attitude" with an ability multi-task and prioritise as appropriate.
* 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.

Education
* 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.


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