Job Description
A Bioprocess Associate is required to work in a commercial large-scale drug substance manufacturing facility, responsible for equipment operation, monitoring, and maintenance in accordance with current Good Manufacturing Practices (cGMPs).
About PSC Biotech
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, with global operations in Ireland, India, Singapore, Australia, and the US, serving clients worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services.
Job Description
PSC Biotech is seeking a Bioprocess Associate to join our team. As a key member of our manufacturing operations group, you will be responsible for the preparation, operation, and monitoring of equipment, use of business systems, and carrying out tasks including cleaning, validation, in-process testing, and basic maintenance of equipment in accordance with cGMPs.
Key Responsibilities
- 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, or other colleagues as requested.
- Escalate issues as appropriate to Process Lead.
- Liaise with other groups and individuals to ensure planning of tasks is effective and linked into the manufacturing process plan.
Requirements
- Team worker.
- Ability to work cross-functionally and with multiple stakeholders.
- Troubleshooting capabilities.
- Understanding of Drug Substance Manufacturing Operations.
- Understanding of GMP requirements in a Bio-pharmaceutical Facility.
- Ability to multitask.
Qualifications & Education
- 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.