Website TPM05521
Summary:
Our client, a global biopharmaceutical company based in Limerick is looking for a Downstream Process SME User Rep to work on their new mAbs facility. The successful candidate will be accountable for process design, execution and alignment.
Responsibilities:
- Review /alignment check on all process design deliverables (P&IDs, downstream sections of utility load studies, PRD sizing calculations, etc.).
- Review/alignment check on all Issue for Bid/RFQ downstream package documentation prior to issue to vendors to ensure user requirements are captured.
- Review /comment on pre-award technical clarification meetings with vendors.
- Review /comment on all Issue for Purchase packages prior to PO.
- Review /alignment check on all vendor technical submittals post PO.
- Attendance and input to vendor weekly design meetings and 3D model reviews.
- Attendance at piping 3D model reviews (30/60/90%).
- Attendance at area /room 3D model reviews.
- Offline reviews/alignment checks of overall federated 3D model and addition of user comments.
- Input to consumables design documents (SUFDs, SU component data etc.).
- Attendance at project reviews (HAZOPs, CE marking strategy, etc.).
- Review of I&C stick-built deliverables (instrument datasheets, instrument submittals and drawings).
- Review and input to all CQV documentation (URs, DQs, CMRAs, CLIAs, OV test plans, etc.).
- Input/support to Ops team during Automation FRS development and detailed design.
- Review and input to downstream system Maintenance Assessments.
- Attendance at vendor FATs.
- Attendance at Construction Walkdowns.
- Review and approval of change control documentation (DRNs, CNs, PICCs etc).
Qualifications & Experience:
- Degree qualification in Process, Chemical or Mechanical Engineering or equivalent.
- Must have at least 5 to 10 years’ experience in the pharmaceutical or biotech industry and will have demonstrated competency in process design and management.
- Experience in Process Plant Technical Standards and design.
- Demonstrated ability to establish key relationships with internal and external contacts.
- Provide technical guidance during program design and implementation phase.
- Experience working in a Program environment and understanding the communications/interfaces required to complete project.
- Experience and strong problem-solving skills in process design, execution, start-up and testing activities.
- Knowledge of cGMP’s and other worldwide regulatory requirements.
To apply for this job email your details to orla.daly@tandempm.ie.