Manufacturing Biotech Associate

About PSC Biotech

Who 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:

A fantastic and exciting opportunity has arisen for a
Manufacturing Biotech Associate that will work in a manufacturing self -directed
shift team to deliver batch operations successfully, identify and resolve
issues in order to allow the site to deliver for our patients in a culture that
supports Quality, EHS, Learning and Continuous improvement.

Requirements

Responsibilities:

• 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 process 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 .
  
• Maintain/ support a high standard of safety/ Good
  Manufacturing Practice (GMP) compliance at all times.
  
• Determine solutions by referencing relevant past
  experiences as part of problem solving activities.
  
• Get actively involved by participating in inspections,
  GEMBA’s and Go -See’s.
  
• Act as a team member on process deviation reviews and
  Gemba walkdowns.
  
• Mentor new members of staff in specific plant activities.
  
• Be prepared to answer auditor questions during site
  walkdowns.
  
• Engage in implementing innovative solutions that drive a
  high performance organisational culture that accommodates rapid growth and
  highly dynamic expectations ensuring attainment of site operational and
  development goals.
  
• Utilize Lean Six Sigma Tools to support the initiative of
  continuous improvement (CI) projects to increase agility, flow, throughout and
  reduce cycle time and inventory.
  
• This is a 24/7 shift role