Senior Specialist -Process Engineer

PSC Biotech Ltd; Dublin; Híbrido; EUR 90.000 - 130.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work schedule

In-house training & mentorship

Exposure to top pharma clients

Descripción de la vacante

PSC Biotech Corporation seeks a Senior Specialist - Engineering to ensure compliant design, construction, qualification and operation of a new state-of-the-art facility in Ireland. The role will lead technology transfer, process development and continuous improvement across multi-disciplinary teams.

The ideal candidate has 5–7 years of relevant experience in pharma/biotech and solid knowledge of GMP, CQV, and regulatory filings. Hybrid onsite requirement and early 2027 start are specified.

Formación

• Minimum 5 years' (MSc) or 7 years' (BSc) directly related experience in academia, pharma or biotech.
• Knowledge of current regulatory requirements and GMP.

Responsabilidades

• Lead design, construction, qualification and operation of the new facility during initial phase.
• Support upstream & downstream equipment design, qualification and tech transfer.
• Apply Lean Six Sigma tools and lead problem solving & risk assessment (FMEA).
• Author batch docs, technical reports and regulatory submissions.
• Collaborate with manufacturing science, quality, analytics and regulatory teams for process improvements.

Conocimientos

Process Engineering

Pharma manufacturing

Regulatory compliance

Lean Six Sigma

Data analysis

Statistical methods

Educación

Bachelor's degree in Biological Sciences/Chemical Engineering

Master's degree (MSc) in related field

Herramientas

JMP

Design Expert

Descripción del empleo

• Industry Pharma/Biotech/Clinical Research
• Work Experience 5+ years
• City Dublin
• State/Province Dublin
• Country Ireland

Job Description

About PSC Biotech

Who are we?

PSC Biotech is a leading Biotech Consultancy firm foundedin 1996, headquartered in Pomona, California, USA, with Global operations inIreland, India, Singapore, Australia and the US, serving 350 clients in morethan 23 countries worldwide. We provide cloud-based software solutions forQuality Management and Regulatory Inspections, pharmaceuticals contractmanufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy modelby aligning our EVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like-minded professionalsoperating in the Pharma/ Biotech Industry. We offer a permanent contract ofemployment giving exposure of working in Top Pharmaceutical client sites in adiverse-cultural work setting.

Employee Value Proposition

Employees are the “heartbeat” of PSC Biotech, we provideunparalleled empowering career development though Learning & Developmentin-house training mentorship through constant guidance to facilitate careerprogression. We believe in creating high performing teams that can exceed ourclient’s expectations with regards to quality of all scalable and business unit

Overview

The Senior Specialist - Engineering’s role will beessential in ensuring efficient and effective compliant design, construction,qualification, approval and operation of the new state-of-the-art facilityduring the initial project phase. The successful candidate will take a lead onutilising the latest innovations in technology and automation to create aworkplace of the future.

Requirements

Role:

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

Additional Info:

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

The Candidate should have:

• This role requires an experienced individual with aminimum of 5 years’ (for MSc) or 7 years’ (for BSc) directly related experiencein academia, pharmaceutical or biotechnology company – along with a workingknowledge of current regulatory requirements and current Good ManufacturingPractices.
  
• A self-starter and results-focussed, the successfulcandidate will have strong contemporary knowledge, and the ability to workindependently and on multidisciplinary teams. The successful candidate willalso have demonstrated the ability to deliver what is needed on-time, holdingself and team accountable for commitments, decisions, actions and behaviours.
  
• S/he will also have excellent oral and writtencommunication skills, with the ability to effectively articulate understandingof 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 BiologicalSciences/Chemical Engineering/Biological Engineering/Chemistry (or PhD withoutindustry experience), the successful candidate will also ideally have a proventrack record in delivering excellence. The candidate will also show ambitionand drive to develop and advance their career
  

Preferred Experience and Skills:

• Experience with upstream cell culture and/or downstreampurification of biological molecules.Experience with technology transfer, regulatory filing, and commercialdrug substance manufacturing of biologics is a plus.
  
• Technical operations experience in the drug substancemanufacture of biological molecules at commercial-scale.
  
• Prior experience in drug substance process development,process characterisation studies, process performance qualification andvalidation, site readiness, batch record reviews, authoring regulatory CTDsections and/or working with external contract organisation for developmentand/or manufacturing.
  
• Working knowledge of statistical methods for DOE designand 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