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 [HIDDEN TEXT] and send your resume in MS Word format. Note that only shortlisted candidates will be contacted.

Drug Linker SME (Contract - Pharmaceutical)