Bioprocess Associate

Job Description About PSC Biotech   Who we are?
  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.
Role Description: This role will be part of Manufacturing Self Directed work team/ Hub in our new state of the art single use multi-product biotech facility.
The organisational structure at the site will be based on self-directed work teams (SDWT) where decisions will be made at the level where the data exists.
The BTA is responsible for all procedures and processes associated with the manufacture of Drug Substance at manufacturing facility, at the highest standards of Safety, Quality and Compliance.
The BTA will be responsible for undertaking manufacturing operations involved in the production of biologic drug substance on their designated shift.
Key responsibilities include the execution of an automated recipe using paperless technology to progress the drug substance through inoculation and cell culturing activities, leading to filtration and purification of the product in a state-of-the-art single use technology-based facility.
The incumbent will be involved in setting up the single use equipment between runs, carrying out the production process according to world class GMP and EHS principles.
The BTA will also be involved in driving to optimise and improve the processing activities through use of standard work and lean processing techniques while supporting operations team to consistently deliver on specific Key Performance Indicators (KPIs).
At all times this role is focused on delivery to the patient through living the culture including a commitment to safety, focusing on right first time in everything we do and a concentrating on the engagement and development of self and peers.
Requirements Role Functions: Primary responsibilities include but not limited to: Support operations team to consistently deliver on specific Key Performance Indicators (KPIs), e.g.
Environmental Health and Safety (EHS) metrics, Production Plan, Overall Equipment Effectiveness (OEE), compliance and team training.
Complete COMMIT cards to highlight ways of working within our SDWT's and Hubs and across our site that support our COMMIT culture.
Provide immediate feedback to others at any time to reinforce good safety and improvement behaviours and acts.
Execute commercial manufacturing processes according to established work instructions and Standard Operating Procedures (SOPs).
Ensures that all assigned task related to manufacturing documentation support is in accordance with good manufacturing practices.
Routinely talk about any safety issues you are concerned about.
Work as part of a dedicated proess team where flexibility and teamwork are a key requirement.
Generate SOPs/ Work Instructions (WIs) to ensure compliance with regulatory standards.
Adhere to Right First-Time principles.
Provide assistance and/or support maintenance, engineering, quality or other colleagues as requested.
Escalate issues as appropriate to manager/designee.
Maintain a high level of personal expertise and working knowledge of all aspects of the manufacturing process and process equipment through continuous training and development.
Liaise with other groups and individuals to ensure planning of tasks is effective and linked into the manufacturing process plan and site schedule.
Challenge and identify improvements to the safety and environmental programmes on site.
Celebrate with use of proactive recognition tools that inspire teams and individuals you collaborate with.
Take part in shift handovers and tier 1 meetings, raising concerns or issues promptly and providing options for resolutions.
Act as an ERT during emergency situation if trained.
Experience, Knowledge & Skills: General Competencies: Demonstrate success in a team environment in either a project or work related activities.
Demonstrate troubleshooting competency.
Desire to learn and develop.
Technical: Understanding of Drug Substance Manufacturing Operations.
Understanding of GMP requirements in a Biopharmaceutical Facility.
Excellent communication skills and the ability to work in a cross functional collaborative environment.
Qualifications & Education: Level 7 qualification in a science or engineering discipline, or level 6 with a minimum of 1 - 3 years' experience in a GMP Manufacturing environment.
This role is a site-based role.
This role will involve working Shifts, on a 24/7 basis.
#LI-EL1 Requirements Role Functions: · Primary responsibilities include but not limited to: · Support operations team to consistently deliver on specific Key Performance Indicators (KPIs), e.g.
Environmental Health and Safety (EHS) metrics, Production Plan, Overall Equipment Effectiveness (OEE), compliance and team training.
· Complete COMMIT cards to highlight ways of working within our SDWT's and Hubs and across our site that support our COMMIT culture.
· Provide immediate feedback to others at any time to reinforce good safety and improvement behaviours and acts.
· Execute commercial manufacturing processes according to established work instructions and Standard Operating Procedures (SOPs).
· Ensures that all assigned task related to manufacturing documentation support is in accordance with good manufacturing practices.
· Routinely talk about any safety issues you are concerned about.
· Work as part of a dedicated proess team where flexibility and teamwork are a key requirement.
· Generate SOPs/ Work Instructions (WIs) to ensure compliance with regulatory standards.
· Adhere to Right First-Time principles.
· Provide assistance and/or support maintenance, engineering, quality or other colleagues as requested.
· Escalate issues as appropriate to manager/designee.
· Maintain a high level of personal expertise and working knowledge of all aspects of the manufacturing process and process equipment through continuous training and development.
· Liaise with other groups and individuals to ensure planning of tasks is effective and linked into the manufacturing process plan and site schedule.
· Challenge and identify improvements to the safety and environmental programmes on site.
· Celebrate with use of proactive recognition tools that inspire teams and individuals you collaborate with.
· Take part in shift handovers and tier 1 meetings, raising concerns or issues promptly and providing options for resolutions.
· Act as an ERT during emergency situation if trained.
Experience, Knowledge & Skills General Competencies: · Demonstrate success in a team environment in either a project or work related activities.
· Demonstrate troubleshooting competency.
· Desire to learn and develop.
Technical: · Understanding of Drug Substance Manufacturing Operations.
· Understanding of GMP requirements in a Biopharmaceutical Facility.
· Excellent communication skills and the ability to work in a cross functional collaborative environment.
Qualifications & Education: · Level 7 qualification in a science or engineering discipline, or level 6 with a minimum of 1 - 3 years' experience in a GMP Manufacturing environment.
· This role is a site-based role.
· This role will involve working Shifts, on a 24/7 basis.
#LI-XA1