About the Role
Anter Consulting is looking for a Project Engineer to support our pharmaceutical biologics clients in Singapore. You will be embedded within the site engineering team, supporting facility modification projects and new equipment introduction in a live GMP manufacturing environment. This is a hands-on role covering the full project lifecycle from design and planning through construction, commissioning and handover.
Key Responsibilities
Project Execution
- Manage and support facility modification projects including architectural, mechanical and M&E works in a cGMP-regulated biologics environment
- Lead new equipment introduction activities from URS development and vendor engagement through procurement, installation, commissioning and qualification
- Develop project scope, schedules and budget estimates track progress and flag risks to ensure on-time, within-budget delivery
- Coordinate FAT and SAT activities with vendors and internal stakeholders review and approve vendor documentation submissions
- Support change control, site modification requests and all associated GMP documentation throughout the project lifecycle
- Maintain full project documentation including drawings, specifications, meeting minutes, progress reports and technical records
Construction & Site Supervision
- Supervise contractor and vendor works on site, ensuring execution aligns with approved design drawings, specifications and site safety standards
- Review contractor method statements, risk assessments and work execution schedules approve permit applications for high-risk activities (confined space, hot work, lifting, work at height)
- Conduct site walkdowns, inspections and quality checks to verify workmanship meets project and regulatory requirements
- Coordinate tie-in works and system integration with operations, utilities and M&E teams
Commissioning & Qualification
- Manage IQ/OQ and where applicable PQ activities for new or modified equipment and systems in line with site validation strategy
- Prepare, review and execute commissioning and qualification protocols and summary reports
- Manage punch list development, tracking and closure through to operational handover
- Liaise with QA and Validation teams to ensure qualification activities are completed compliantly and on schedule
Stakeholder Management
- Act as key interface between Engineering, QA, Validation, Operations and external vendors throughout the project lifecycle
- Participate in cross-functional project meetings and provide regular status updates to site leadership
- Manage contractor and vendor performance against agreed quality, cost and schedule commitments
Requirements
- Degree or Diploma in Mechanical Engineering, Chemical Engineering, Biomedical Engineering or a related discipline
- Minimum 4 years of project engineering experience in a pharmaceutical or biologics manufacturing environment
- Proven experience in facility modification projects - architectural, mechanical or M&E works - within a GMP-regulated site
- Hands-on experience in equipment introduction, commissioning and qualification (IQ/OQ/PQ)
- Good understanding of cGMP documentation standards, change control and validation requirements
- Experience managing contractors, vendors and cross-functional stakeholders
- Ability to read and interpret P&IDs, engineering drawings and equipment specifications
