Pharmaceutical Engineer - CQV (Contract - Tuas)

RMA Contracts Pte Ltd; Singapore; On-site; SGD 90,000 - 120,000; Full time

Job summary

RMA Contracts Pte Ltd is seeking an experienced CQV Engineer to lead commissioning, qualification and validation efforts within our Singapore project teams. You will develop CQV strategies, plan scope, and coordinate with engineering, operations, and external vendors to ensure safety and quality from start to finish.

You should hold a Bachelor's degree in Engineering and have 5+ years of field CQV execution experience with familiarity in Risk Based Validation.

Qualifications

• Must have experience with Risk Based Validation methodologies.
• Field CQV execution experience required; familiarity with CQV lifecycle.
• Pharmaceutical/chemical processing knowledge is essential, including commissioning, qualification and validation activities.

Responsibilities

• Lead CQV activities including commissioning, qualification and validation per C&Q plan.
• Develop strategies and procedures to support CQV execution.
• Plan and manage CQV scope, schedule and interfaces with Engineering, Operations and external vendors.

Skills

Risk Based Validation

Field CQV execution

Education

Bachelor's degree in Engineering (Chemical, Mechanical, Process, or related)

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

EA LicenceNo: 93C4403

EA RegnNo: R1326974