Senior Qualification Engineer

2 days ago

Singapore Bayer Full time

**Senior Qualification Engineer**

**YOUR TASKS AND RESPONSIBILITIES**:

- Management (incl. resource management) and coordination of Commissioning & Qualification (C&Q) activities across all project phases for projects of medium and above complexity (e.g., new technologies, increased number of interfaces, brownfield, new process, new/unknown product, etc).
- Development and maintenance of a schedule for C&Q activities.
- Development and management of a C&Q team of external and internal employees.
- Interface management to coordinate all C&Q activities with internal and external project functions including Operations and the responsible QA/QC organizations. In case of conflicts, actively contribute to the solution.
- Accompanying support of commissioning activities and document creation.
- Responsible for the timely creation of commissioning plans, qualification plans, test plans, test reports and qualification results.
- Responsible for the creation and documentation of a higher-level C&Q concept, Validation Master Plan (VMP), workflows, and RACI.
- Coordination/ support in the implementation of quality impact assessment and GMP risk analysis.
- Participation in the creation of the User Requirement Specs (URS) and ensuring consistent congruence with the documents based on it(e.g., Risk analysis, Qualification plans).
- Active participation in the project team and regular information of the project team about the status of the C&Q activities.
- Description of contractual services and commissioning of external C&Q services in coordination with procurement.
- Support of the GMP and gate Reviews by providing the required C&Q documents (see Gate Deliverable List (GDL).
- Support Bayer internal GMP auditor, to conduct Bayer internal GMP auditing for Bayer sites in Asia.

**WHO YOU ARE**:

- Degree in pharmaceutical engineering, process engineering or equivalent, with at least 5 year practical experience in the C&Q environment.
- Knowledge of current GMPs, best practices and relevant regulations / guidelines.
- Ability to have an overview of several projects in parallel.
- Capable to build and lead an effective C&Q team in a project environment
- Capable of working well with people across all hierarchies
- Capable to deal with uncertainties and conflicts.
- Strong analytical problem-solving and decision-making skills.
- Sound understanding of Health, Safety, and Environmental (HSE) requirements;
- Empower for Inclusion and Diversity, learning agility and passion for digitalization, sustainability and technology trends
- Willingness to execute projects at remote locations under travel (up to 50%) or project assignment across the Asia Pacific region.

**YOUR APPLICATION**-
**IMPORTANT NOTE for POTENTIAL CANADIAN CANDIDATES**: This position requires full vaccination against COVID-19.**Location**:

- Singapore : Singapore : Singapore**Division**:

- Enabling Functions**Reference Code**:

- 787208

  • Senior Engineer Reliability

    1 week ago

    Singapore Infineon Technologies Full time

    You will define reliability assessment plan for new package technologies with a failure mechanism-based approach and determine the technical capability of a package technology to meet the specified reliability requirements In your new role you will: - Define **reliability assessment plan **for **new package technologies **with a failure mechanism-based...

  • Commissioning & Qualification Engineer

    4 days ago

    Singapore CAI Full time

    The Commissioning & Qualification Engineer's responsibility will be to provide technical oversight on behalf of client of a third party commissioning team responsible for the C&Q efforts in the Warehouse/Dispensary/Drumstore Buildings. The primary equipment in the Warehouse/Dispensary/Drumstore consists of three Dispensaries, a Subdivision Suite and Sampling...

  • QC Qualification Engineer

    2 weeks ago

    Singapore NO DEVIATION PTE. LTD. Full time

    About No deviation At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to...

  • QC Qualification Engineer

    3 days ago

    Singapore NO DEVIATION PTE. LTD. Full time $80,000 - $120,000 per year

    About No deviationAt No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful...

  • Graduate Qualification Engineer

    3 days ago

    Singapore Resmed Full time $60,000 - $80,000 per year

    Imagine working with a global team of more than 10,000 talented people who are committed to creating the world's best medical technology. Imagine a role where your skills and attributes will contribute to improving millions of lives.Because at ResMed, you will.Let's talk about the teamJoining ResMed's Verification & Validation team will give you access to...

  • Graduate Qualification Engineer

    2 weeks ago

    Singapore Resmed Full time

    Imagine working with a global team of more than 10,000 talented people who are committed to creating the world's best medical technology. Imagine a role where your skills and attributes will contribute to improving millions of lives. Because at ResMed, you will. Let's talk about the team Joining ResMed's Verification & Validation team will give you...

  • Commissioning & Qualification Engineer - Thermal

    4 days ago

    Singapore CAI Full time

    The Commissioning & Qualification Engineer will work with a Thermal Oxidiser vendor to ensure smooth execution of vendor’s Site Acceptance Testing. The role includes C&Q execution on other process equipment as required and is not exclusive to the Thermal Oxidiser. **Role Responsibilities** Abide by all safety requirements and procedures and serve as a...

  • Commissioning, Qualification and Validation Engineer

    1 week ago

    Singapore Wood PLC Full time $90,000 - $120,000 per year

    Remarkable people, trusted by clients to design and advance the world.Wood is currently recruiting for a Commissioning, Qualification and Validation Engineer to support our growing operations in Singapore. You will be responsible for the execution of project work in accordance with company procedures within the man-hour and cost budgets.#LI-OnsiteThe RoleAs...

  • Engineer Reliability and Qualification

    4 days ago

    Singapore Infineon Technologies Full time

    I **n your new role you will: D** - **efine reliability assessment plan f**or new package technologies with f**ailure mechanism-based approach and determine the technical capability o**f a package technology to meet the specified reliability requirements(including set-up of customer mission profile) I - dentify new failure modes, d**etect unexpected...

  • VVQ (Verification, Validation, and Qualification) Manager

    4 days ago

    Singapore Manpower Singapore Full time

    VVQ (Verification, Validation, and Qualification) Manager We are seeking a motivated and experienced Team Manager to lead our Verification, Validation, and Qualification (VVQ) team. The successful candidate will be responsible for managing all VVQ activities to ensure that products and systems comply with functional, quality, and regulatory requirements....