Process Engineer

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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.

Overview:

New exciting opportunity now exists on our Carlow 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

Responsibilities:

• 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 Carlow 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 in Carlow
  
• May be required to perform other duties as assigned
  
  Skills Required:
  • 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
    
  • 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
    
  • Hybrid role once successful completion of training, occasional shift support as required based on program needs
    

Job Description

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.

Overview:

New exciting opportunity now exists on our Carlow 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

Responsibilities:

• 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 Carlow 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 in Carlow
  
• May be required to perform other duties as assigned
  
  Skills Required:
• 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
  
• Hybrid role once successful completion of training, occasional shift support as required based on program needs
  

Requirements
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
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