Introduction
We at Rieckermann Singapore are on an exciting journey of growth and are looking for a dynamic Regional Commissioning and Qualification (C&Q) Support Engineer for our Engineering Operations (EO) portfolio to help us achieve our vision to become your first-choice industrial solution provider. At Rieckermann, we value your unique skills, talents, and contributions at every stage of your career. Here, you can shape your professional journey and explore our wide industry expertise. Make your impact in a collaborative, international work environment with a long-standing tradition of upholding quality, commitment, and trust.
Rieckermann provides comprehensive consulting and engineering solutions, working with multinational pharmaceutical clients to R&D facilities - across all spectrums of the industry from chemical API, secondary, biopharmaceutical to medical device designers and manufacturers.
Our team offers the comprehensive suite of services; - including training, regulatory compliance, auditing, qualification and engineering. Additionally, we offer a range of OEM equipment and tools for the pharmaceutical industry, complete with training, turnkey installation, commissioning, qualification, and maintenance services.
Role
The Regional C&Q Support reports to the C&Q Lead and is focused on engaging the packaged equipment/system suppliers and facilitating with project C&Q deliverables for SGOPs ADC Manufacturing Facility, including but not limited to:
- User Requirement Specifications (URS)
- Requirements Traceability and Testing Matrix (RTM)
- Receipt Verification (RV)
- Inspection Test Plan (ITP)
- Design Review (DR) / Design Qualification (DQ)
- Pre-FAT testing
- Factory Acceptance Testing (FAT)
- Stage Gates (A0, A1)
- Vendor Turnover Package (VTOP)
Responsibilities
- On-site presence - Located primarily at main supplier factory location during design, fabrication, FAT, and pre-shipment phases; required to travel and be embedded with other vendors/suppliers during critical execution and preparation, as applicable.
- Quality by Design (QbD) and C&Q lifecycle alignment and coordination - Close liaison with packaged equipment/system suppliers to align on C&Q test approach and deliverables derived from Validation Master Plan (VMP) and C&Q Execution Plan (CQEP) to agreed scope, schedule, quality, and safety.
- Stakeholder and interface management - Serve as regional representative and focal point between suppliers and AZ stakeholders including C&Q Program Manager, C&Q Lead, Quality Lead, Subject Matter Experts (SMEs) and/or System Owners to align on C&Q requirements.
- Suppliers management - Manage deliverables such as Vendor Turnover Packages (VTOPs), Construction Turnover Packages (CTOPs), suppliers Inspection Test Plan (ITP), Factory Acceptance Testing (FAT) protocols and Site Acceptance Testing (SAT) protocols, where applicable, as part of C&Q documentation lifecycle delivery. Ensure completeness and quality of Vendor Turnover Packages (VTOPs) to enable smooth transition into site C&Q (CTOP, SAT, IQ/OQ). Readiness management -Drive vendor readiness for Design Qualification (DQ), Pre-FAT, and FAT by ensuring documentation, test protocols, and systems are aligned and approved ahead of execution.
- Compliance - Ensure deliverables comply with regulatory, quality and SHE standards. Implement global standards and procedures and maintain audit-ready documentation. Define and enforce compliance for the scope area. Set metrics and intervene to correct performance as needed, especially related to non-compliance, quality risk, or deviation from approved requirements. Key understanding of the design and relevant aspects to C&Q – able to notify and flag where construction is making changes against approved design without client approval / notification. Perform technical reviews of supplier design documentation (e.g. P&IDs, specifications, control strategies) to ensure compliance with URS and GMP requirements, as applicable (RTM/DQ). Ensuring all documentation generation and data entries follow Good Documentation Practices (GDP).
- Controls and reporting - Establish integrated controls for risks, changes, issues, and progress. Provide transparent reporting against performance baselines and the master plan, escalating and driving recovery actions when required. Provide continued oversight (QbD) of fabrication, documentation, and construction testing activities real progress. Provide visibility on constraints, and risks (e.g. fabrication limitations, local practices, workshop constraints) that may impact project delivery.
- Schedule accountability - Own scope schedules; track commitments, forecasts, and variances; and manage schedule performance to deliver within approved parameters.
Job Requirements
- University degree in Engineering, Life Sciences or equivalent
- Minimum 5 years experience in commissioning and/or validation of biopharmaceutical equipment and processes
- Experienced working in a pharmaceutical or GMP/GLP environment is preferred, although cross-industry expertise is welcomed
- Willing to travel for a long period around Europe as required.
- Experienced working under Quality Management Systems
- Excellent interpersonal and communication skills
- Goal-oriented, dynamic, and high sense of responsibility
- Able to work flexibly and under pressure
- Able to work self-reliantly
- Possess excellent customer-oriented work-ethic
- Professional appearance and demeanor
- Very good written and verbal English skills
