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Senior Process Engineer

Reference ID : 123MQ
Category :
  • Pharma / Biotech
Date Posted : Jun 19, 2020
Job Location
:
  • Leinster
- Carlow
Experience : 5+ Years
Salary : Negotiable - DOE
Employment Type
:
Contract
Consultant
:
Michael McQuade
Contact Number : 086-0435195
Headcount Engineering is seeking a Process Engineer for New Product Introductions at our clients Biologics facility.

Principal Responsibilities

The selected person will join the Process Engineering Group on site and report to the NPI Coach. They will serve as technical support for new product introduction (NPI) and commercial manufacturing.

The suitable person will typically have prior related work experience; ideally in manufacturing, preferably GMP setting.

Main 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 revalidation
  • 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
  • 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
  • Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups. 
  • Drive compliance of Company 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.

Qualifications & Requirements

  • Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline
  • Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner
  • Demonstrable analytical and systematic problem-solving skills
  • Ability to effectively manage complex projects across multiple disciplines
  • Technical 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 information please contact Mick on 086-0435195 or forward details in confidence to jobs@headcount.ie



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