Design lead - (API Production) Singapore
Advanced Manufacturing Tech Solutions (AMTSOL) · Singapore ·
- Seniority
- Lead
- Employment
- Contract
- Category
- Design
- Experience
- 5+ years
Design lead / subject-matter expert supporting engineering design for an API (active pharmaceutical ingredient) production facility in Singapore. Day to day: writing technical and user requirement specs, managing design contractor deliverables, reviewing drawings and calculations, and ensuring GMP and SHE compliance across systems such as reactors, filter dryers, chromatography and freeze dryers.
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