Formulation Engineer -Drug Product

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
deliverables, staying under budget and ensuring timelines for our deliverables
are being met.

Responsibilities:

• Provide technical leadership within a new Vaccine Drug
  Product Manufacturing facility.
  
• Ensure all equipment installed is safe, effective and in
  compliance with industry standards.
  
• Ensure all company and site engineering policies and
  procedures are adhered to.
  
• Provide technical and compliance review and/or authorship
  of testing protocols, reports and applicable manufacturing SOPs.
  
• Generate and execute documentation for cGMP activities
  including risk assessments /reports.
  
• Management of Equipment Vendors including execution of
  on -site maintenance visits, management of continuous improvement projects &
  spare parts criticality assessments.
  
• Support/lead maintenance of the validated state of the
  equipment through execution of revalidation protocols as per Site VMP.
  
• Lead and participate in cross -functional teams to
  troubleshoot and resolve technical issues, drive continuous improvement, and
  process optimization using tools such as DMAIC and FMEA.
  
• Manage changes to equipment/process as per site change
  control procedures.
  
• Support establishment of new Preventative Maintenance
  Program for equipment in Drug Product suite.
  
• Lead/participate in equipment related manufacturing
  investigations with cross -functional teams to ensure that detailed root cause
  analysis & impact analysis is completed and appropriate CAPAs are
  implemented.
  
• Identify process and equipment improvements and develop
  these into CI projects.
  
• Support disposition of batches by addressing any
  potential technical / engineering related issues which may have occurred
  mid -batch.
  
• Lead/participate in, TPM, CI & Gemba programs and
  daily / weekly tiered manufacturing meetings.
  
• Provide technical expertise during regulatory inspections
  e.g. FDA, HPRA inspections to defend systems, change controls, investigations
  and qualification packages.
  
• Support transition from project to sustaining
  manufacturing and ramp up of production volumes in future by improving
  equipment reliability through CI and TPM processes.
  
• This is a 11 Month Contract role
  

Requirements

Requirements:

• Minimum 5 years cGMP industrial / engineering experience,
  
• Experience in executing on the floor activities such as
  FAT, SAT, IQ/OQ
  
• Experience in data driven approach to root cause analysis
  and prioritization of continuous improvement initiatives e.g. Six Sigma
  
• Experience in leading & resolving complex technical
  investigations.
  
• Experience in a risk -based approach to manufacturing
  through use of tools such as FMEA
  
• Ability to adapt to changing priorities as project
  demands change.
  

Education:

• Bachelor of Engineering or Science Degree in Engineering
  or Technology related discipline.
  

Other Skills, Abilities & Experience:

• Specific experience with Autoclave, Parts Washers, and
  CIP/SIP equipment.
  
• Knowledge of Formulation processes.
  
• Experience in start -up facilities is advantageous.
  
• CQV experience is advantageous.
  
• Knowledge of industry/ regulatory requirements such as
  Annex 1 desirable.
  
• Ability to explain complex technical issues to external
  customers / agencies.
  
• Demonstrated excellence in planning and organizational
  skills.
  
• Demonstrated skills in communication (oral and written)
  & in particular technical writing.
  

Reporting to: Engineering Lead