Senior Specialist -Process Engineer

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

Overview

The Senior Specialist - Engineering’s role will be
essential in ensuring efficient and effective compliant design, construction,
qualification, approval and operation of the new state-of-the-art facility
during the initial project phase. The successful candidate will take a lead on
utilising the latest innovations in technology and automation to create a
workplace of the future.

Requirements

Role:

• Reporting through the site manufacturing and technology
  head and based at the site, the Senior Specialist, Process Engineering
  responsibilities include, but are not limited to the following:
  
• Support the design, construction and qualification of
  upstream & downstream equipment through to technology transfer and
  commercialization. 
  
• Support establishment of the commercial process and
  routine manufacturing by:
  
• Supporting experimental design, execution, data analysis
  and interpretation.  
  
• Interpreting trends observed in commercial process
  monitoring (e.g., proactive process analysis (PPA), continued process
  verification (CPV), statistical process control (SPC) multivariate analyses
  (MVDA)), and for further technical investigations and process changes that seek
  to drive improvements to yield and/or robustness.
  
• Supporting deviation management.
  
• Supporting change control prioritization and
  implementation.
  
• Authoring and reviewing of batch documentation, technical
  reports and global regulatory submissions.
  
• Supporting multidisciplinary teams (manufacturing science
  and technology, quality, analytics, regulatory) for process improvement and
  troubleshooting with end-to-end product focus.
  
• Applying Lean Six Sigma tools by:
  
• Securing continuity of an appropriate LSS/CEM level of
  knowledge.
  
• Facilitating problem solving & risk assessment (FMEA)
  projects/meetings.
  
• Making problems visible and strive for continuous
  improvement.
  
• Serving as a key member during internal audits and
  external inspections/audits
  
• Lead and support various manufacturing science and
  technology organizational initiatives as needed (examples include safety,
  financial forecasting, work standardization, etc).
  
• Maintain continuous focus on quality and safety
  compliance and unflinching focus on the customer.
  

Additional Info:

• Potential requirement to go on shift for 3 weeks only (4
  days on - 2 days, 2 nights, 4 days off)
  
• Hybrid requirement – The successful candidate must work 3
  days onsite each week, and one of those onsite days must be either Monday or
  Friday.
  
• The position is scheduled to start on 4 January 2027, and
  alternative start dates are not being considered.
  
• New requirement for a new tech transfer project – This
  role supports a new technology transfer (Tech Transfer) project. Candidates
  with NPI (New Product Introduction) and/or Biopharma industry experience will
  be preferred during the shortlisting process.
  

The Candidate should have:

• This role requires an experienced individual with a
  minimum of 5 years’ (for MSc) or 7 years’ (for BSc) directly related experience
  in academia, pharmaceutical or biotechnology company – along with a working
  knowledge of current regulatory requirements and current Good Manufacturing
  Practices.
  
• A self-starter and results-focussed, the successful
  candidate will have strong contemporary knowledge, and the ability to work
  independently and on multidisciplinary teams. The successful candidate will
  also have demonstrated the ability to deliver what is needed on-time, holding
  self and team accountable for commitments, decisions, actions and behaviours.
  
• S/he will also have excellent oral and written
  communication skills, with the ability to effectively articulate understanding
  of process science, in order to drive decision making, impact assessments,
  design of studies, etc., in a multi-disciplinary team environment.
  
• With a Bachelor’s degree (or higher) in Biological
  Sciences/Chemical Engineering/Biological Engineering/Chemistry (or PhD without
  industry experience), the successful candidate will also ideally have a proven
  track record in delivering excellence. The candidate will also show ambition
  and drive to develop and advance their career
  

Preferred Experience and Skills:

• Experience with upstream cell culture and/or downstream
  purification of biological molecules.   Experience with technology transfer, regulatory filing, and commercial
  drug substance manufacturing of biologics is a plus.
  
• Technical operations experience in the drug substance
  manufacture of biological molecules at commercial-scale. 
  
• Prior experience in drug substance process development,
  process characterisation studies, process performance qualification and
  validation, site readiness, batch record reviews, authoring regulatory CTD
  sections and/or working with external contract organisation for development
  and/or manufacturing.
  
• Working knowledge of statistical methods for DOE design
  and data analysis (e.g., JMP or Design Expert software)
  
• Working knowledge of statistical process control (SPC),
  multivariate analysis (MVDA), and/or process analytical technologies (PAT)
  techniques for biologics processes