This is an 11-month 24/7 shift – 33.33% Shift Premium
A fantastic opportunity has arisen for a contract Bioprocess Associate. You will be responsible for all procedures and processes associated with the Manufacture of Commercial Large-Scale Drug Substances 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).
Work with the manufacturing operations group, project design team, the CQV team, and 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 principles.
Provide assistance and/or support maintenance, engineering, quality
Escalate issues as appropriate to Process Lead
Liaise with other groups and individuals to ensure the planning of tasks is effective and linked into the manufacturing process plan.
A level 6 with a minimum of 3 years experience in a GMP Manufacturing requirement shall be deemed equivalent.
Minimum of a Level 7 qualification in a science or engineering discipline.
In order to excel in this role, you will more than likely have:
Ability to work cross-functionally and with multiple stakeholders.
Understanding of Drug Substance Manufacturing Operations.
Understanding of GMP requirements in a Bio-pharmaceutical Facility.