Package Lead Engineer - Freezers & Cold Storage - Pharma

Advanced Manufacturing Tech Solutions (AMTSOL)

A SME in Life science Manufacturing Technology solutions, we are looking for top talent to be part of the dynamic team and drive the growth of the business. Work location in Singapore.

Role –

Package Lead Engineer – Freezers & Cold Storage – Capital Projects - Bio Pharma

Job Summary

The Package Lead Engineer supports the Project Coordinator and Project Manager (Packaging & Logistics) in ensuring the EPCM contractor delivers to agreed scope, schedule, cost, quality, safety and compliance requirements. Up to FAT, the Package Lead focuses on monitoring, coordinating, reviewing, interfacing and governing EPCM performance; after FAT, the Package Lead takes ownership of driving the package through to handover.

The Package Lead Engineer coordinates the EPCM and internal project teams (including CQV), manages stakeholders, tracks progress and risks, and ensures design intent adherence, regulatory and client standards compliance, and documentation readiness through design, procurement, construction, commissioning and turnover.

Scope areas include (but are not limited to):

• Freezers and thaw units
• Cold storage
• Other peripheral equipment in warehouse and chemical warehouse facilities

Responsibilities -

Package Leadership & Governance:

• Act as package lead / area lead within the project, managing committed deliverables with responsibility for the budget and schedule for the assigned scope
• Assist the Project Coordinator / Project Manager within project leadership in planning and delivering the defined work scope to agreed schedule and budget
• Responsible for cost and schedule, and for ensuring the work package meets all stage-gates associated with delivery
• Serve as the key contact for the package from supplier selection through to operationally qualified status
• Coordinate with project members and client stakeholders, including SMEs, CQV, vendors and procurement, to define and drive the work package delivery schedule
• Support the Project Manager in ensuring compliance with the client project delivery process throughout the project lifecycle, and obtain necessary certifications and approvals from client representatives
• Prepare regular project reports and presentations for key stakeholders

Risk, Compliance & Change Management:

• Define, manage and secure capable resources to support critical studies (FMEA, RCA, HAZOP), monitor progress and risks, and report to stakeholders
• Ensure compliance with engineering, SHE, GMP and GEP standards and procedures so that assets satisfy business needs and external regulators, promoting a positive Health & Safety culture
• Identify and assess commercial, design and schedule risks, mitigate impacts and escalate to management when appropriate
• Manage potential scope changes, ensure change requests are communicated to the project team, and lead complex problem-solving investigations as necessary
• Collaborate with colleagues and manage interfaces within the project, ensuring accountability for integrated activities

Vendor, Installation & Qualification:

• Actively manage supplier / vendor performance to meet project quality, cost and schedule
• Contribute to the planning and execution of the sourcing strategy and manage technical and commercial supplier / vendor issues, escalating as needed
• Coordinate activities with construction, installation teams and equipment suppliers during equipment installation, and conduct effective work sessions
• Organise, manage and follow up on FAT, SAT and qualification execution and documentation, ensuring closure of deviations and compliance with system lifecycle documentation, including as-built drawings and O&M packages
• Participate in Mechanical Completion walkdowns, manage punch items, and assist with commissioning, qualification and system start-up

Requirements

• Proven experience leading work packages and managing resources (typically 1–5 people, matrix / dotted-line) on Pharmaceutical / Biopharma capital projects
• Understanding of CQV processes
• Understanding of operational and user requirements
• Competence in ensuring compliance with design specifications, SHE standards, operational requirements and maintenance considerations
• Ability to interpret technical drawings, specifications and project documentation
• Excellent communication skills, including issue escalation, expectation management and alignment with project governance
• Competence in compliance with engineering, GMP/GEP and SHE requirements
• Able to work effectively with senior management, end users, SME teams, site operations, EPCM / design companies, contractors, suppliers and consultants
• Willing to work on site in Singapore

Desirable

• Post-graduate engineering qualification
• Mandarin language skills (for engagement with Chinese vendors)