Senior Specialist, Process Engineering

Orion Group Life Sciences are currently recruiting a Senior Specialist, Process Engineering on behalf of our Multinational Biopharmaceutical Client based in Dublin on an initial 12-Month contract with potential to extend. Hybrid Position 3 days onsite.
 
The Opportunity
Dublin, Ireland has been chosen for a first-ever Large-Scale Mammalian-Based Drug Substance Facility. This facility will be a significant supplier of drug substance for one of the company's key treatments and will also be critical in the future supply of new biotechnology products to its global network.
Construction on this exciting new facility will commence immediately and this is a unique opportunity for the right person to shape, create, build and grow the capabilities of the Dublin facility, which will support the manufacture of biologics-based medicines, including in the area of immuno-oncology.
As one of the hires in this ambitious project, 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.
 
The Role
Reporting through the site manufacturing and technology head and based at the Dublin 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 at the Dublin facility 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 striving 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.

 
The Candidate
This role requires an experienced individual with a minimum of 5 years’ (for MSc) or 7 years’ (for BSc) directly related experience in academia or the pharmaceutical industry – along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.
A self-starter and results-focused, 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.
They 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 within the organisation.
 
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 organisations 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.

 


People are our business worldwide
 
Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.