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.
