Technical Validation Engineer

PSC Biotech

  • Carlow
  • Permanent
  • Full-time
  • 1 month ago
  • Apply easily
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.

Responsible for providing process, technical, and validation support operations including ongoing support of manufacturing processes and support for new product introduction. Accountable for analytical/engineering studies associated with the development of new components, products, processes systems and facilities. Co-ordination, design and execution of equipment qualification. and validation as required.

Responsibilities:
  • Serve as technical and/or validation support as required for manufacturing and new product introduction.
  • Design/Author/Review/Approve/Execute process development studies in support of new product introduction and ongoing manufacturing support.
  • Provide technical input into quality notification by authoring/reviewing/approving investigations.
  • Execution of equipment commissioning and qualification programs
  • Execution of equipment/qualification validation programs; including re-qualification and re-validation
  • Design/Author/Review/Approve/Execute qualification/validation documentation and studies in line with the standard approval process
  • Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis
  • Support continuous improvement through Lean Six Sigma methodologies.
  • Leading and active participation in projects, system failure investigations and investigation reports,
  • Execution/development of change controls
  • Contribution to Kaizen events as appropriate.
  • Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.;
  • Implement subsequent corrective action through the change management system.
Requirements
  • Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline
  • 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
  • Lean Six Sigma Methodology experience desired
  • Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner
  • Understand the specific responsibilities of all Carlow departments as they relate to ones own department, understanding the business processes ones department supports
  • Customer service
  • Vendor liaison
  • Strong influencing skills
  • Self-motivated
  • Flexible approach
  • Effective time management and multi-tasking skills
  • Excellent attention to detail
  • Trouble shooting skills
  • Data Analysis

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