Process Engineer (NPI)

PSC Biotech Ltd; Pomona (CA); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading biotech consultancy firm in Pomona seeks a Process Engineer to join their team. You will provide technical support for new product introductions and commercial manufacturing, ensuring compliance with GMP regulatory standards. Ideal candidates have a Bachelor's degree in a technical field and at least three years of related experience. This role offers opportunities in a dynamic environment with a focus on continuous improvement and technical excellence.

Qualifications

• Min 3 years of experience ideally in manufacturing, preferably GMP Setting.
• Demonstratable experience of leading technical related projects.
• Evidence of continuous professional development is desirable.
• Knowledge of regulatory/code requirements to Irish, European and International Codes.
• Knowledge of sterile filling processes and equipment.

Responsibilities

• Design/Author/Review qualification/validation documentation.
• Technical input into quality notifications.
• Perform root cause analysis of system failures.
• Drive compliance of Global Policies and regulatory requirements.
• Work collaboratively to drive a safe and compliant culture.

Skills

Bachelor’s Degree or higher preferred

3 years experience in manufacturing

Experience leading technical projects

Knowledge of process monitoring systems

Knowledge of regulatory/code requirements

Equipment and process validation

Proficiency in Microsoft Office

Excellent communication skills

Education

Bachelor’s Degree in Science, Engineering or Technical discipline

Tools

DeltaV

Pi System

Job description

• Industry Pharma/Biotech/Clinical Research
• Work Experience 4-5 years
• City Carlow
• State/Province Carlow
• 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 Careerto 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 ValueProposition

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 unitdeliverables, staying under budget and ensuring timelines for our deliverablesare being met.

Overview:

New exciting opportunity now exists on our Carlow Sitefor a Process Engineer to join the Process Engineering Group on site and reportto the Technical Engineering Manager

Our new team member will serve as technical support fornew product introduction (NPI) and commercial manufacturing and willparticipate and/or lead cross functional or single function teams includingliaising with vendors or above site groups. You will typically have priorrelated work experience; ideally in manufacturing, preferably GMP Setting butwe will consider applicants from other working environments as long as theyhave technology transfer experience

Knowledge of process monitoring systems, automation systems(DeltaV), operational intelligence & data systems (Pi System) within a GMPmanufacturing environment would be beneficial and desirable but not a necessityfor this role

Our Engineers support internal and external manufacturingoperations remain operational, continuously improve and innovate. With ourextensive range of facilities and environments, our Engineers haveopportunities 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/Executequalification/validation documentation and process development studies in linewith the standard approval process
  
• Design/Author/Review/Approve/ExecuteExecution/development of change controls
  
• Contribution to Kaizen events as appropriate
  
• Technical input into quality notification byauthoring/reviewing/approving investigations
  
• Execution of equipment/qualification validation programs;including re-qualification and re-validation
  
• Support continuous improvement through Lean Six Sigmamethodologies
  
• Perform root cause analysis of system failures,substandard performance, using standard tools and methods, to resolve machineand system issues
  
• Serve as technical engineering representative forinternal technical group discussions and represent technical Operations Carlowat global technical forums
  
• Drive compliance of Global Policies, Procedures andGuidelines, regulatory requirements and execute current Good manufacturingPractices (cGMP) in the performance of day to day activities and all applicablejob functions, ensuring consideration of the impact on GMP and compliance anddecisions made. Accountable for compliance via documentation completion, riskassessments, closing out corrective action, participate in audits andinspections and proactively highlighting any issues around compliance
  
• Work collaboratively to drive a safe and compliantculture in Carlow
  
• May be required to perform other duties as assigned
  

Skills Required

• Bachelor’s Degree or higher preferred; ideally in aScience, Engineering or other Technical discipline
  
• Min 3 years experience ideally in manufacturing,preferably GMP Setting
  
• Demonstratable experience of leading technical relatedprojects
  
• Evidence of continuous professional development isdesirable
  
• Knowledge of process monitoring systems, automationsystems (DeltaV), operational intelligence & data systems (Pi System)within a GMP manufacturing environment would be beneficial and desirable butnot 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 computerapplications required
  
• Excellent communication, presentation, and interpersonalskills, to interface effectively with all levels of colleagues and withexternal customers in a team orientated manner
  
• Hybrid role once successful completion of training,occasional shift support as required based on program needs