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