Sr Engineer, Validation
- Solothurn, Switzerland
The incumbent understands industry-wide and Regulatory expectations for validation, and works with other members of management to ensure validation practices are consistent with requirements and expectations; utilizes industry experience to drive the assessment and improvement of site validation practices; functions as the Solothurn representative on global Validation initiatives; ensures that site validation practices meet corporate requirements; collaborates with site Quality Assurance to determine an agreed-upon path forward on matters of Validation philosophy, implementing those philosophies agreed-upon into the Standard Operations of the department; defends validation protocols and explains concepts and policies to Regulatory inspectors; develops and manages studies to respond to Regulatory observations; manages the development of Validation Project Plans, Annual Validation Assessments, and similar summary documents; manages the development execution, tracking, and review of validation testing protocols for completeness, cGMP and data acceptability.
- Manages key validation projects in close collaboration with Quality Engineering and other departments.
- Assesses overall validation workload, staffs accordingly, and deploys resources to attain Manufacturing Engineering & Facilities (MEF) and production goals. Manages and tracks the execution of all relevant validation activities within the Manufacturing and Laboratory areas, integrating their timeline with ongoing projects and programs.
- Coordinates tracking of validation protocol execution status and ensures completion of validation projects per required schedules.
- Interacts with people from all departments to resolve issues.
- Coordinates participation on Tech Transfer, and cross-functional teams including global Validation,, CMC, start-up
- Bachelor of Science Degree (BSc) in an engineering or scientific discipline.
- A minimum of 10-12 years related experience and/or training; or an equivalent combination of education and experience.
- Practical knowledge and application of GMPs, GLPs, and EMEA and ISO regulations.
- Experience dealing with FDA and/or Swissmedic investigators, authoring responses to critical, major or minor observations and implementing corrective measures.
- Experience in coordinating / leading cross-site or cross-functional initiatives.
- Proficiency in, MS Word, MS Excel, and MS PowerPoint.
- Requires excellent oral and written communication skills.
Back to top