Job Summary:
Serves as the onsite manufacturing lead for our client's Third-Party Manufacturer (TPM) Operations team and is responsible for transferring new products and processes from R&D into production, as well as sustaining post-transfer projects. This is achieved through organization, schedule adherence, and alignment with overall program objectives. The role provides dedicated local leadership to drive execution of all activities required to establish compliant, robust, and fully validated manufacturing processes. Accountable for manufacturing related technical documentation, facilitating cross-functional alignment, and ensuring the timely completion of projects at TPM.
Job Scope:
Process Development, Design Transfer, and Sustaining

Write process specifications and equipment requirements in collaboration with cross-functional teams and TPM stakeholders.
Own the development and maintenance of process documentation, including SOPs, work instructions (WIs), inspection plans, validated parameter settings, pFMEAs, DOEs, and validation protocols and reports (IQ, OQ, PQ, TMV).
Review and provide feedback regarding line design, capacity estimates, and cycle time analyses developed by the TPM.
Lead process monitoring activities and manage KPIs such as first-pass yield, machine uptime, and failure rates at the TPM, while driving sustaining and continuous improvement initiatives.
Ensure materials, equipment, personnel training, and quality controls are fully prepared and approved for commercial production.
Assess, manage, and execute change control activities that impact product design or validated manufacturing processes.
Participate in the development of technical project plans and schedules covering all site-level engineering activities.

Project Leadership & Execution

Support the development and execution of technical project plans and detailed schedules for all engineering activities at the TPM site.
Report on project status, including progress, risks, milestones, deliverables, and provide routine updates to Operations Management.
Maintain cross-functional alignment across Operations, Quality, Supply Chain, and global stakeholders.

Requirements:

Bachelor's degree in Engineering, Science, or a related technical field.
8+ years of experience in the medical device or similar regulated industry, with a focus on manufacturing, NPI, or process engineering roles.
Hands-on experience in process development, equipment installation and commissioning, and FAT/SAT activities.
Demonstrated experience leading process improvement and cost-reduction initiatives.
Solid foundation in general engineering principles.
Proven expertise in process validation (IQ, OQ, PQ) within a regulated environment.
Working knowledge of Quality System Regulations (ISO 13485 and/or 21 CFR 820), with experience in medical device risk management per ISO 14971

Core Competencies

Regulatory and Quality Focus - solid understanding of medical device regulations and manufacturing compliance
Technical Depth - Solid expertise in process development, equipment installation, and validation requirements
Execution Discipline - Effectively manages complex project timelines with structure and accountability
Risk-Based Thinking - Skilled in risk assessment, mitigation planning, and decision-making under uncertainty
Cross-Functional Collaboration - Works effectively across engineering, quality, operations, and global teams
Adaptability - Thrives in ambiguous environments with evolving requirements and accelerated timelines

Additional Information:

Salary - Up to S$12K + 1-month bonus
Contract duration: 12-month contract, extendable
Commencement Date: Immediate
Working days and hours: Monday to Friday, 9am to 6pm
Location: Bugis, frequent traveling to Johor Malaysia

Lyn, Yee Chen Fu EA License No. 02C3423 Personnel Registration No. R1110796

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Senior Process & Validation Specialist (NPI / TPM), 12-month, CBD