Staff Engineer高级工程师-MSAT

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MSAT Staff Engineer

Position Summary

This role provides dedicated ownership of a CMO portfolio representing approximately 85% of the site's manufacturing volume. The position is responsible for translating customer requirements into actionable project plans, ensures seamless customer engagement, effective execution of projects, successful management of evolving customer needs, and the alignment of cross-functional resources to support sustainable business growth and uninterrupted product supply.

Key Responsibilities

Customer Relationship Management

• Serve as the primary customer-facing contact for all CMO-related activities.
• Understand customer needs and expectations and ensure effective translation into site execution plans.
• Provide timely updates on project progress, risk assessments, and issue resolution.

Life Cycle Management (LCM)

• Lead and coordinate LCM initiatives for CMO products, including:
  • Process changes and optimization
  • Process validation activities
  • Cleaning validation activities
  • Packaging and artwork changes
  • Regulatory-driven changes
• Ensure projects are delivered on time, within scope, and in compliance with applicable quality and regulatory requirements.

Project Management

• Translate customer requirements into structured and executable project plans, timelines, milestones, and deliverables.
• Lead and coordinate cross-functional activities across MSAT, Quality, Operation, GETs, Procurement, Regulatory Affairs and other relevant functions.
• Drive execution of customer commitments while ensuring alignment with site priorities and business objectives.
• Identify project risks, develop mitigation plans, and escalate critical issues as appropriate.

Qualifications

Education

• Bachelor's degree or above in Pharmaceutical Sciences, Chemical Engineering, Biotechnology, or related disciplines.

Experience

• Minimum 8 years of experience in pharmaceutical manufacturing, MSAT, supply chain, project management, technical operations, or related functions.
• Experience working with Contract Manufacturing Organizations (CMOs) or external customers is highly preferred.
• Experience leading cross-functional projects in a GMP-regulated environment.
• Knowledge of pharmaceutical product lifecycle management.

Technical Knowledge

• Strong understanding of pharmaceutical manufacturing processes.
• Knowledge of validation activities, including process validation and cleaning validation.
• Familiarity with packaging operations and commercialization processes.
• Understanding of GMP, quality systems, and regulatory requirements.

Competencies

• Excellent project management and organizational skills.
• Strong customer-facing and stakeholder management capabilities.
• Ability to convert complex customer requirements into actionable execution plans.
• Strong communication and influencing skills across multiple organizational levels.
• Proven ability to manage multiple priorities in a dynamic and changing environment.
• Strong problem-solving and risk management capabilities.
• Fluent in English, both written and verbal.

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