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.
