Process Leader

3 weeks ago


Singapore STA PHARMACEUTICAL SINGAPORE PTE. LTD. Full time
Roles & Responsibilities

Job title: Process leader

Reporting line:

Direct Reports: Engineering Director

Job overview:

As the Process leader, Lead Singapore API engineering activities, ensuring cGMP compliance with Singapore HSA, FDA 21 CFR Part 211, and ICH Q7 requirements. Drive technical excellence in synthetic peptide & high-potency API manufacturing facility design and optimization.

Core Responsibilities

1. Requirements Management & Design Development

ü Lead User Requirements Specification (URS) development by consolidating inputs from China-based stakeholders and also Singapore inputs, ensuring alignment with operational and cGMP needs.

ü Generate Basis of Design (BOD) documentation and provide technical inputs to Singapore design institutes for Front-End Engineering Design (FEED) development.

2. Design Phase Technical Control

ü Develop Mass & Energy Balance (MEB) for continuous manufacturing systems.

ü Design Closed Processing Systems for OEB 4/5 compounds with 3D modeling to meet Singapore requirement.

ü Chair Design Review Meetings at critical milestones (30%/60%/90% phases), resolving interface conflicts between architectural, process, and utility disciplines.

ü Implement V-model approach for design verification, ensuring traceability from URS to Functional Specifications (FS).

ü Perform Gap Analysis against ASTM E2500 standards, documenting deviations in Engineering Change Requests (ECRs).

ü Conduct 3D model reviews for constructability analysis and HAZOP studies for high-risk process areas .

3. Construction & Commissioning Management

ü Execute CQV (Commissioning, Qualification and Validation) protocols for process systems, including:

FAT/SAT witness testing for GMP-critical equipment

DQ/IQ/OQ documentation review and approval

ü Manage Punch List closure process, coordinating multi-trade walkdowns for system handover.

ü Oversee As-Built Drawings verification against red-line markups, ensuring compliance with GEP standards.

4. Compliance Review & Risk Management

ü Lead Safety Design Reviews during Conceptual Design (CD), Basic Design (BD), and Detailed Design (DD) phases per OSHA PSM standards.

ü Maintain cGMP Design Log tracking critical parameters (e.g., cleanroom ISO classifications, material segregation protocols).

ü Develop Risk Assessment Matrix for construction activities, implementing mitigation plans for high-risk tasks.

5. Documentation & Knowledge Management

ü Establish Turnover Package system for construction deliverables, including:

Certified Material Records (CMTRs)

Pressure Test Packages

Calibration Certificates

ü Develop Lessons Learned Database capturing design improvements and construction best practices.

6. Team Leadership & Capability Building

ü Implement Competency Matrix for technical staff development, conducting quarterly Gemba Walk assessments.

ü Lead Cross-Functional Tiger Teams to resolve critical path issues during peak construction periods of Singapore project.

ü Design Mentorship Programs focused on ISPE Baseline Guides and GAMP 5 methodologies with Singapore project team members.

7. Cross-functional Strategic Support

ü Serve as APAC-Singapore Technical Liaison, aligning China facility practices with Singapore greenfield project requirements (ICH Q7 compliance).

ü Participate in Global Engineering Standards Committee to harmonize design specifications across regions.

Job requirements:


• Knowledge of cGMP


• Bachelor degree or above in chemical, mechanical, electrical/electronic engineering and other related majors


• Strong technical knowledge coupled with hands-on working experience in a pharmaceutical / biotech / fine chemical facility


• 15 years of working experience in start-ups, commissioning & qualification of process systems in an operating plant is a plus


• Excellent leadership and communication skills


• Ability to lead teams including external contractors


• Excellent team player willing to work for the common goal


• Mentoring and coachingskills


• Extensive communications with stakeholders in China, ability to speak and write in Mandarin fluently to liaise and work with Mandarin-speaking internal and external partners. Chinese Proficiency Test Level 6 is preferred.

Tell employers what skills you have

3D Modeling
Requirements Management
Constructability
FDA
Asbuilt Drawings
HAZOP
Knowledge Management
GAMP
Traceability
3D
Vmodel
Facility Design
Pressure
Technical Liaison
Staff Development
Calibration

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