Process Engineer

7 days ago

Carlow, Ireland PSC Biotech Ltd Full time
About PSC Biotech

Who we are?
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. 

Role Description:

  • Process Engineer - Tech Transfer / NPI
  • Hybrid – Day's role with expectation to support shift intermittently when Floor activities/studies are ongoing.
  • New exciting opportunity now exists on our Client Site for a Process Engineer to join the Process Engineering Group on site and report to the Technical Engineering Manager
  • Our new team member will serve as technical support for new product introduction (NPI) and commercial manufacturing and will participate and/or lead cross functional or single function teams including liaising with vendors or above site groups. You will typically have prior related work experience; ideally in manufacturing, preferably GMP Setting but we will consider applicants from other working environments as long as they have technology transfer experience.
  • Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable but not a necessity for this role.
  • Our Engineers support internal and external manufacturing operations remain operational, continuously improve, and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.


Requirements

Role Functions:

  • Design/Author/Review/Approve/Execute qualification/validation documentation and process development studies in line with the standard approval process.
  • Design/Author/Review/Approve/Execute Execution/development of change controls.
  • Contribution to Kaizen events as appropriate
  • Technical input into quality notification by authoring/reviewing/approving investigations
  • Execution of equipment/qualification validation programs; including re-qualification and re-validation
  • Support continuous improvement through Lean Six Sigma methodologies.
  • Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues.
  • Serve as technical engineering representative for internal technical group discussions and represent technical Operations at global technical forums.
  • Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made. Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance.
  • Work collaboratively to drive a safe and compliant culture.
  • May be required to perform other duties as assigned.

Experience, Knowledge & Skills:

What you will do: 

Bring energy, knowledge, innovation, and leadership to carry out the following:

  • Design/Author/Review/Approve/Execute qualification/validation documentation and process development studies in line with the standard approval process.
  • Design/Author/Review/Approve/Execute Execution/development of change controls.
  • Contribution to Kaizen events as appropriate
  • Technical input into quality notification by authoring/reviewing/approving investigations
  • Execution of equipment/qualification validation programs; including re-qualification and re-validation
  • Support continuous improvement through Lean Six Sigma methodologies.
  • Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues.
  • Serve as technical engineering representative for internal technical group discussions and represent technical Operations at global technical forums.
  • Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made. Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance.
  • Work collaboratively to drive a safe and compliant culture.
  • May be required to perform other duties as assigned.

What skills you will need:

  • Bachelor's Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline
  • Min 3 years' experience ideally in manufacturing, preferably GMP Setting
  • Demonstratable experience of leading technical related projects
  • Evidence of continuous professional development is desirable.
  • Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable but not a necessity.
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices Report, standards, policy writing skills required.
  • Equipment and process validation
  • Sterile filling processes and equipment
  • Proficiency in Microsoft Office and job-related computer applications required.
  • Excellent communication, presentation, and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner

Qualifications & Education:

  • Bachelor's Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline
  • Min 3 years' experience ideally in manufacturing, preferably GMP Setting


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