About this role
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
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