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Lead C&Q Engineer

I7808

DPS are looking for Lead C&Q engineer to take responsibility for the successful execution of the C&Q effort from early design stage to IQ/OQ Completion for complete filling operation.

Category:
Engineer Commissioning & Qualification
Location:
Munster
Years of Experience Req.:
10 years
Date Posted:
20/11/2019
Days Remaining:
14
Employment Type:
Contract
Education Level Req.:
Degree qualified

DPS are looking for Lead C&Q engineer to take responsibility for the successful execution of the C&Q effort from early design stage to IQ/OQ Completion for complete filling operation.

Key Responsibilities

  • Reporting to DPS C&Q Manager on technical, scheduling and compliance to site standards.
  • Delivery of the C&Q effort for Filling area to meet schedule, client standards and procedures.  This includes the associated control systems controlling the various functionality in the area.
  • Lead, coach and support daily activities for your team of  (7-10) C&Q engineers.
  • Developing the required documentation, inspection at vendor sites, detailed reviews, supervision of installation on site installed by CMT, co-ordinate the start up with associated teams.
  • Work closely with the Technical SME to provide the technical guidance to team to ensure compliance, upholding standards of excellence in design, document generation and execution. 
  • Prepare the detailed plan for the filling area, complete technical review of specifications and procurement packages associated with Equipment, ensuring action by vendors to comply with corrective actions noted in Vendor quality assessments.

 

Requirements:

  • Experience of filling lines incorporating isolator technology.
  • A thorough knowledge of the EU & FDA GMP regulations associated with Fill Finish Equipment. 
  • Input into design effort to ensure requirements built into design
  • Execute vendor expediting visits, auditing at each stage of design
  • Input into User requirement specifications, technically approve all vendor submittals, technical approve protocols and reports.
  • Completion of design reviews and DQ’s for the various sections.
  • Manage FAT in conjunction with FAT co-ordinator of all equipment filling lines components.
  • Experience with developing an integrated commissioning and qualification strategy / protocols 
  • Technical review of vendor and project change controls for impact on design
  • Identify initiatives and address opportunities for efficiency in all areas
  • Ideal candidates for this role will be Degree qualified in Chemical Engineering or Science related with over 10 years experience centered around start up of Filling Line
  • Comprehensive understanding of cGMP requirements for clinical and commercial biopharmaceutical manufacturing and the ability to implement best practices to ensure project is cGMP compliant.
  • Experience of implementing new biopharmaceutical manufacturing processes, specifically sterile fill operations.
  • Ability to present and defend technical aspects of systems
  • The person should have a thorough understanding of the methodologies of commissioning and qualification, should understand the pharmaceutical regulated environment and should be totally familiar with all GMP issues.  
  • Ability to work in a fast-paced, agile environment, demonstrable multitasking and execution skills.
  • Excellent organisational skills, including efficiency, punctuality, and collaboration in a team environment., Excellent interpersonal skills, including communication and presentation.
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