Bioprocess Associate-Shift

About PSC BiotechWho are we? 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 point 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 of 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 though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met. Overview:

• You will be responsible for all procedures and processes associated with the Manufacture of Commercial Large-Scale Drug Substance 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).
• 11 month contract with the possibility to extension.
• Shift work – 4 on / 4 off ( 2 days, followed by 2 nights)

RequirementsBring energy, knowledge, innovation to carry out the following:

• Work with the manufacturing operations group, project design team, the CQV team, 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).
• Execute commercial manufacturing processes according to established work instructions and Standard Operating Procedures.
• Generate SOPS/Electronic Batch Records.
• Adhere to Right First-Time principals
• Aid 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.

What skills you will need:

• Minimum of a Level 7 qualification in a science or engineering discipline.
• Team worker.
• Ability to work cross functionally and with multiple stakeholders.
• Trouble shooting capabilities.
• Understanding of Drug Substance Manufacturing Operations.
• Understanding of GMP requirements in a Bio-pharmaceutical Facility.
• Excellent communication skills.
• Ability to multitask.