C&Q Project Manager

1 month ago

Cork, Ireland DPS Group Global Full time

Lead Commissioning & Qualification Engineer: (Fill Finish)

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 and auto trayloading).

The C&Q lead will report to the DPS Project Manager on technical, scheduling and compliance to site standards. The person will be responsible for delivery of the C&Q effort for Filling line project to meet schedule, client standards and procedures. This includes the associated control systems controlling the various functionality in the area.

The Lead will have a team of C&Q engineers (7-10) 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.

The lead with work with the Technical SME to provide the technical guidance to team to ensure compliance, upholding standards of excellence in design, document generation and execution. They will lead, coach and support daily activities.

The lead will 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 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 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

Requirements:

  • Ideal candidates for this role will be Degree qualified in Chemical Engineering or Science/ Biotech 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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