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Process Engineer

4 months ago

Dublin, Dublin City, Ireland PSC Biotech Corporation Full time
  • Industry Pharma/Biotech/Clinical Research
  • Work Experience 4-5 years
  • City Dublin
  • State/Province Dublin
  • Country Ireland
Job Description

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 points 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.

JobTitle: Process Engineer

ProcessEngineer/Scientist required to work within the Process Development Commercialteam. The team is responsible for providing process and product support to drugproduct and fill finish operations in the client site.

Requirements

Keyresponsibilities listed below but primarily the Hiring Manager can foreseesupport will be needed for the following:

· Day-to-dayoperations support as a subject matter expert in drug product formulation, vialfilling, pre-filled syringe filling, lyophilization and vial capping.

· Productand process investigation support

· Continuousimprovement projects to improve process performance and productivity.

Responsibilitiesinclude:

Thechosen candidate would typically be involved in activities such as (but notexclusively):

· Assessproposed changes to commercial processes under the change control process.

· Reviewand approve changes to operating procedures, electronic batch records, andproduct documentation.

· Generateproduct impact assessments associated with process excursions and deviations,with reference to product technical documentation.

· Supportnew product introduction team, as a process subject matter expert; This wouldinclude but is not limited to, recipe development and protocol execution, aswell as troubleshooting and investigation support.

· Riskassessments and mitigation projects relating to line performance.

· Performprocess gap analysis and developing strategies to close gaps.

· Datatrend analysis for all performance aspects of the area.

· Troubleshootingperformance trends.

The chosencandidate will work in a collaborative manner within the process teams'structure and contribute as a member of cross functional teams within the localorganization and functional team globally.

BasicQualifications:

· Bachelor'sdegree in engineering, Science, or related discipline.

· Demonstratedleadership skills with the ability to build teams and operate across functionalboundaries, both internal and external.

· Significantrelevant industrial project experience.

PreferredQualifications:

· Typically,3-5 years engineering experience in a manufacturing environment

· Qualificationin Lean and 6-sigma methodologies would be an advantage.

· Newproduct introduction or process improvement experience in a GMP environmentwould be advantageous.

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