About Us
PSC Biotech is a leading biotech consultancy firm founded in 1996, headquartered in California, USA, with global operations in Ireland, India, Singapore, Australia, and the US, serving over 350 clients worldwide.
Our EVP
We offer a permanent contract of employment giving exposure to working in top pharmaceutical client sites in a diverse cultural work setting.
Employee Value Proposition
Employees are empowered through Learning & Development, in-house training, and mentorship for career progression. We believe in creating high-performing teams that exceed client expectations regarding quality deliverables.
Job Title: Bioprocess Associate
Role Description
A fantastic opportunity has arisen for a Bioprocess Associate responsible for procedures and processes associated with commercial large-scale drug substance manufacture at our manufacturing facility.
* Work with manufacturing operations, project design team, CQV team, and Automation/CSV reps to develop and validate manufacturing facilities.
* Support equipment design, HAZOP reviews, and room programming.
* Deliver specific area KPIs, such as EHS metrics, Production Plan, OEE, compliance, and team training.
* Execute commercial manufacturing processes according to established work instructions and SOPs.
* 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 to ensure planning of tasks is effective and linked into the manufacturing process plan.
Experience, Knowledge & Skills:
* 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.