Process Design SME (Drug Substance)

Our client is a leading global pharmaceutical company committed to advancing science and delivering life-saving medicines. With a strong presence in Singapore, they are looking to expand their team. Join an innovative and fast-paced environment focused on quality, compliance, and cutting-edge technology. This will be a contract role.

Key Responsibilities:

• Work closely with the Designers to develop the design, translating client technical requirements into the agreed engineering deliverables.
• Work closely with the site operations team and global support such as GTO (as necessary) to have an aligned client position on critical technical areas and communicate with design team in a single unified manner
• Attend all necessary design discussions and provide technical direction to client requirements and drive a risk based ’design to cost’ ethos into the design decision making process for your areas of responsibility
• Coach and support design team to develop User Requirement Specifications (URSs) that are technically complete (eg. CTQs, GMP, GEP and SHE requirements), technically correct and appropriate for C&Q execution
• Review and approve all URSs within technical area as Engineering SME Approver (engineering requirements)
• Review and comment on assigned engineering deliverables produced by EPC & equipment suppliers.
• Attend supplier visits for critical equipment packages (on as required basis)
• Carry out periodic Design Assurance reviews and reporting (30,60,90%), to ensure ongoing technical alignment and identification of value engineering opportunities.
• Provide technical support to SHE risk assessments (HAZOPs, SWIFT, LOPA studies etc.) and ensure key risks are identified and appropriate mitigations are included in the design.
• Work collaboratively with assigned Work Package Owners to ensure the technically compliant delivery of equipment packages Attend supplier visits for critical/ancillary equipment packages (depending on geography and carbon budget considerations)
• Participate in and make recommendations for the procurement strategy for technical work packages including pre-qualification/contractor selection and technical content/scope of contracts.
• Review and comment of BD Design Deliverables within required review periods (with support as required from GTO SME)
• Review and approve DQ protocols for critical equipment packages as they become available
• Ensuring SHE considerations, sustainability targets, relevant SME engagement and client standards are incorporated into proposed solutions
• Work collaboratively with assigned Work Package owners and C&Q partners to ensure the technically compliant delivery of equipment packages.

Requirements:

• Strong experience in Greenfield pharmaceutical CAPEX projects and large-scale biologics facilities
• Strong experience in biopharmaceutical manufacturing, specifically mAbs production.
• Experience with downstream processing equipment, including Single-use bioreactors, Chromatography systems, TFF (Tangential Flow Filtration) skids, Buffer and media preparation systems, CIP (Clean-In-Place) systems, Process transfer lines and vessels, Central dispensing and logistics systems for DS operations
• Experience supporting or leading Conceptual design, Basic design, Detailed design, Equipment specification and selection
• Ability to review and approve: URS (User Requirement Specifications), Design Qualification (DQ) protocols, Engineering deliverables from EPCM firms and vendors
• Experience participating in or leading HAZOP studies, LOPA assessments, SWIFT workshops, Process risk assessments, Design assurance reviews (30%, 60%, 90% reviews)