Design lead - (API Production) Singapore

Advanced Manufacturing Tech Solutions (AMTSOL); Singapore; On-site; SGD 90,000 - 135,000; Full time

Job summary

DL SME seeks an experienced engineering design professional to provide design support for API production. You will engage with stakeholders to capture needs and translate them into technical requirements and design deliverables.

The role requires ensuring GMP, CPP/CQA, SHE compliance, and working with Design Contractors across BD and DD stages. Responsibilities include producing URS, reviewing contractor responses, and contributing to procurement and risk assessments.

Qualifications

• 5–9 years of experience in engineering design and project execution.
• Strong collaboration and ability to challenge behaviours when needed.
• Demonstrated practical problem-solving in complex environments.
• Detail-focused completer with a results-oriented mindset.

Responsibilities

• Engage with key stakeholders to ensure needs are reflected in BD design.
• Prepare Project Technical Requirements Specification for systems and standards.
• Ensure relevant specifications are provided to the Design Contractor.
• Define and agree design deliverables for remaining design stages (BD, DD).
• Review Contractor responses to ensure requirements are included correctly.
• Attend Project meetings as required and contribute actively.
• Ensure URS are produced and cover CPP/CQA/CMA GMP, SHE requirements.
• Participate in procurement strategy for technical work packages.
• Produce regular Design Assurance Reports for technical alignment.
• Identify value engineering opportunities.
• Ensure SHE and GMP compliance requirements are reflected in deliverables.
• Attend SHE risk assessments to ensure mitigations are included.
• Provide technical guidance to Work Package Owner teams.
• Ensure solutions align with customer, cost, and schedule requirements.
• Provide input to Project Planning and bid reviews for systems.
• Review mechanical packages and contribute to project scope.
• Support redundancy strategy and maintenance philosophy.

Skills

Collaboration

Problem-solving

Detail-oriented

Leadership

Job description

DL SME

Scope of Responsibilities

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

Key Responsibilities

• Engage with key 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 and applicable standards.


• Ensure all relevant 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 the Contractor response to the Project Technical Requirements to ensure 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 SHE and GMP compliance requirements are reflected in the design deliverables.


• Attend and contribute to SHE risk assessment activities to ensure alignment with 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 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 and calculations) for each area to ensure correct interpretation of requirements.

Soft skills and expectations (Capabilities, Values and Behaviours)

• 5 to 9 yrs of experience


• Strong collaborator with ability to create and maintain effective working relationships and willing to challenge behaviours and actions.


• Demonstrated practitioner of practical problem-solving.


• Detail focused completer/finisher with a results-orientated mindset.


• Strong leadership qualities with motivational ability to direct others in a dynamic and complex environment through change.


• Collaborate and work in partnership with multiple customer teams to deliver programme/project objectives,


• High profession standards, holding themselves and other in the team to deliver high quality outcomes to committed deadlines.


• Works with integrity and tenacity to 'do the right thing' even under challenging situations and escalates issues appropriately