Key Performance Indicators (Indicate how performance for this role will be measured)
- Quality / Accuracy / Right First Time
- Timeliness
- Deviations / Escalations
Job Dimensions ( Number of staff reporting)
Indicate key facts and figures) Direct: 0
Financial responsibility (Budget, Cost, Sales, etc.)
Operational Budget: na
Impact on the Organization
- Contribute to increased level of automation in manufacturing
- Significant impact on ensuring competitive advantage in quality and costs by improving the relevant data and digital technology standards
- Contribute to Site Manufacturing financial / business goals.
- Minimize process-related rejected batches and write- offs.
- Maximize process robustness
Skills:
- Good Documentation Practice
- Effective communicator
- Strong cross functional collaboration
- Adaptability to Embrace Change
- Effective stakeholder engagement
- Manufacturing Process
- Knowledge Of GMP (Good Manufacturing Practices)
- Change Control
- Deviation management
- Corrective and preventive action (CAPA)
- Continual Improvement Process
- General HSE Knowledge
- Manufacturing (Production)
Ideal Background / Requirements for the role
Education (minimum):
University degree in Engineering, Computer Sciences, Technology (Chemical/Biology) or similar field
Languages
- Fluent in English and additional languages desirable (German, French, other)
Relevant Experiences
- 5 years of practical experience in the pharmaceutical industry, with expertise in manufacturing IT systems.
- Hands-on experience with Biovias Discoverant and Pipeline Pilot tools.
- Knowledge of integrated IT systems such as ERP (SAP), MES, LIMS, OSI-PI, SQL, Oracle/MS SQL databases, and cloud-based data storage solutions.
- Comprehensive understanding of pharmaceutical cGMP, Computerized System Validation (CSV), and regulatory requirements.
- Familiarity with statistical tools and programming languages such as Minitab, JMP, Python, and R is a plus.
- Knowledge of data handling applied statistics, and Six Sigma methodologies.
- Proven ability to collaborate effectively with team members, site experts, and organizational leaders, with a capacity to influence without direct authority.
- Solid project management and presentation skills, with the ability to lead cross-functional initiatives.
- Excellent communication and interpersonal skills to foster collaboration and drive results.