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MS&T Senior Bioprocess Engineer
4 weeks ago
About PSC Biotech
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.
'Take your Career to a new Level'
PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling points, which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/Biotech Industry. 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 the "heartbeat" of PSC Biotech. We provide unparalleled empowering career development through Learning & Development, in-house training, and mentorship through constant guidance to facilitate career progression. We believe in creating high-performing teams that can exceed our clients' expectations regarding the quality of all scalable and business unit deliverables, staying under budget, and ensuring timelines for our deliverables are being met.
Overview:
An exciting opportunity has arisen for a MS&T Senior Bioprocess Engineer.
Role Functions:
- Responsible for the participation in and leading of key technology transfer activities in support of clinical and commercial new product introduction projects.
- Development of strategies for and support in the execution of technology transfer, process, and cleaning validation programs in line with company, industry, and regulatory standards.
- Acting as process Subject Matter Expert in the support of process investigations.
- Use of risk management techniques to assess strategies, prioritize activities, and initiatives.
- Lead other significant business-critical projects on-site associated with new product introduction and site capability build.
- Acting as system owner and Subject Matter Expert (SME) to support investigations and using risk management techniques to prioritize activities and initiatives.
- Ongoing optimization of process equipment and development of future breakthrough business solutions.
Experience, Knowledge & Skills:
- Minimum of 6 years in a biologics drug substance environment.
- Technical expertise in biological drug substance upstream and/or downstream purification unit operations required.
- Experience in technology transfers for clinical or commercial biologics strongly desired.
- Experience with automated systems highly desired.
- Process validation and cleaning validation experience desired.
Qualifications & Education:
- Minimum of a Bachelor's Level 8 degree in a technical field (e.g., Engineering, Science, or equivalent), with experience in the biotechnology or pharmaceutical industry.
