Senior Qualification Engineer

3 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

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