Drug Linker SME (Contract - Pharmaceutical)

Drug Linker SME (Contract until Dec 2028 – Tuas)

Our Client is a multinational Pharma and Biotech leader constructing a billion dollar ADC manufacturing facility in Singapore.

SCOPE OF WORK

• Engineering design support for API production which may include
• Chemical warehouse
• Material transfers and logistics
• Purification (Chromatography and Evaporation)
• Freeze Dryer
• Reactors
• Filter dryers
• Solvent Break tanks to support Chromatography

• Engage with key Client stakeholders to ensure that their needs are understood and reflected in the BD design.
• Prepare Project Technical Requirements Specification for all systems specifying performance requirements & applicable Client's Standards
• Ensure all relevant Client's specifications are provided to the Design Contractor.
• Define & agree with Design Contractor necessary design deliverables for all remaining design stages (BD, DD) - Design Deliverables List made Project Specific including the level of review appropriate to these documents.
• Review Contractor response to the Project Technical Requirements to ensure Client's requirements are correctly included.
• Attend Project meetings on an as required basis.
• Ensure User Requirement Specification (URSs) are produced and are complete, CPP/CQA/CMA GMP, GEP and SHE requirements), technically correct and appropriate for C&Q execution.
• Participate in and make recommendations for the procurement strategy for technical work packages including pre-qualification/contractor selection and technical content/scope of contracts.
• Produce regular Design Assurance Reports according to the plan set up by the PTM, to ensure ongoing technical alignment.
• Identify value engineering opportunities.
• Ensure key Client's SHE and GMP compliance requirements are reflected in the design deliverables.
• Attend and contribute to SHE risk assessment activities to ensure alignment with Client's SHE requirements and ensure appropriate mitigations are included in the design.
• Provide technical guidance to Work Package Owner teams within their areas of responsibility.
• Ensure specific technical solutions are consistent with Client's Customer, cost and schedule requirements.

• Provide input to Project Planning.
• Review / involvement with mechanical packages.
• Support development of redundancy strategy and maintenance philosophy.
• Review & input to Sustainability Checklist.
• Respond to Construction queries where the Design Contractor is unable to provide answers.
• Answer Design Contractor queries as required.
• Review Design Contractor enquiry specifications for specific items (define which) and involvement in the bid review / selection for these systems.
• Review a sample of documentation (drawings & calculations) for each area to ensure correct interpretation of Client's Requirements.

If you are keen to know more about this role, please email Mary at [Confidential Information] and send your resume in MS Word format. Note that only shortlisted candidates will be contacted.