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