Pharmaceutical Engineer - CQV (Contract - Tuas)

RMA CONTRACTS PTE. LTD.; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

RMA CONTRACTS PTE. LTD. is seeking a CQV professional to manage commissioning, qualification and validation activities across assigned systems.

You will develop strategies, lead cross-functional teams including EPCM and external vendors, and ensure documentation quality aligns with CQEP and project plans. Key requirements include a Bachelor's in engineering, 5+ years of field CQV execution, familiarity with risk-based validation, and ATEX/process safety knowledge for drug linker contexts.

Qualifications

• Bachelor's degree in Engineering (Chemical, Mechanical, Process, or related discipline).
• Familiar with methodologies related Risk Based Validation.
• Extensive experience in areas/systems under future responsibility. Minimum of 5 years is preferable.
• Field CQV execution experience.
• For Drug Linker: Knowledge of ATEX, process safety, and pharmaceutical engineering standards.

Responsibilities

• Ensure CQV activities are executed per the C&Q Execution Plan and supporting Plans.
• Develop strategies and procedures to support CQV execution.
• Plan and execute commissioning activities for allocated areas.
• Lead and coordinate C&Q execution with EPC teams, Engineering, Operations, and external vendors.
• Support development of C&Q schedule for scope.
• Coordinate planning and scheduling with HSE, Automation, Electrical, Instrumentation, and other disciplines.
• Guide CQV documentation to ensure correctness and alignment across systems.
• Lead preparation activities (start-up, procurement, vendors selection).
• Coordinate with vendors for CQV related activities.
• Lead coordination meetings to tune commissioning preparation and execution with involved parties.
• Report CQV status, progress and issues at project stakeholders meetings.
• Review and approve CQV test scripts.
• Track and address discrepancies per CQEP; plan and execute mediation actions.
• Support control of changes; assess cost, schedule and compliance.
• Ensure CQV milestones are completed per baseline schedule.
• Liaise with EPCM/Vendors on design and construction issues.
• Participate in construction walk-downs and snag list for Mechanical Completion.
• Ensure quality standards are followed; avoid significant regulatory observations.

Skills

CQV execution

Risk Based Validation

Field CQV experience

ATEX knowledge

Education

Bachelor's degree in Engineering

Job description

Scope of Work

• Ensure that Commissioning, Qualification, and Validation (CQV) activities are executed in accordance with the Commissioning and Qualification (C&Q) Execution Plan and supporting Plans.
• Development of strategies and procedures that support their execution scope.
• Overall planning and execution of the commissioning activities related to allocated areas or systems.
• Leading and coordinating the C&Q execution effort supported by C&Q EPC teams,Engineering, Operations, and external vendors and contractors
• Support development of C&Q schedule for associated scope.
• Coordinating the planning and scheduling of activities with supporting disciplines (HSE,Automation, Electrical, Instrumentation, Operation and Engineering, etc.
• Guiding C&Q documentation preparation effort to ensure correctness, completeness and alignment across different areas/systems.
• Lead preparation activities (e.g. start-up, procurement, vendors selection, etc)
• Coordination and interfacing with vendors for C&Q execution related activities.
• Lead coordination meetings to fine-tune the commissioning preparation and execution with all involved parties
• Reporting of C&Q status, progress and issues during project stakeholders meetings (e.g.Tier 2 meetings, Wall meetings).
• Review and approve CQV test scripts
• Ensure discrepancies encountered are adequately reviewed and approved in accordance with CQEP. Tracking of these deficiencies, including planning and executing there mediation actions
• Support the control of changes, ensuring cost, schedule and compliance are correctly assessed.
• C&Q execution milestones are completed as per baseline schedule
• Ensures C&Q field execution is completed in a safely manner and following Site EHS standards.
• Liaising with EPCM/Vendors on design and construction issues.
• Participate in construction walk-downs and snag list of these systems for Mechanical Completion.
• Ensure that quality standards are followed during C&Q execution. No significant observations in external regulatory inspections for allocated process area.
• This role reports to the C&Q Manager
• This role is outsourced to our Client.

Requirements

• Bachelor's degree in Engineering (Chemical, Mechanical, Process, or related discipline)
• Familiar with methodologies related Risk Based Validation
• Extensive experience in areas/systems under future responsibility. Minimum of 5 years is preferable
• Field CQV execution experience.
• For Drug Linker: Knowledge of ATEX, processsafety, and pharmaceutical engineering standards