Process SME

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.