Experienced Validation Engineer (f/m/x)

For our client, an international company based in Bern, we are looking for an Experienced Validation Engineer.

In this role, you will be responsible for Qualification and Validation activities for new QC laboratory department. The Experienced Validation Engineer is primary responsible that Qualification and Validation studies are carried out conform to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities. Under general supervision performs technical work, provides validation and project management services and/or develops concepts, assessments, and details under moderate supervision. Carries out the all the validation tasks and as needed the Experienced Validation Engineer will be able to design and execute independently all the validation activities and interpret the results to properly make final statement of the validation outcome.

General Information:

• Start date: ASAP
• End date: end of project 31.01.2025
• Workplace: Bern
• Workload: 100%
• Home office: possible up to 2 days per week

Tasks and Responsibilities:

• Define strategy, plan, coordinate and execute the core business phases of Qualification and Validation activities based on specific assigned role and responsibilities.
• Ensure the Qualification and Validation activities are properly planned and executed as per Lifecycle Process Validation process.
• Ensures the validation activities are reported back in the applicable site Supporting Validation Plans and Validation Master Plans.
• Authoring, review and approve validation plans, protocols, reports.
• Perform risk/criticality assessments, technical and GMP related documentation.
• Bridging with multi-functional teams handling and ensuring facilities, equipment, and process readiness for GMP production.
• Works with greater autonomy for longer term activities independently interpreting data, identifying project needs, and proposing solutions.
• Collects and collates results and inferences and reports to project team and senior colleagues.
• Collaborates effectively with fellow project members following priorities, checkpoints, and timelines in support of objectives.
• Define strategy, plan, coordinate and execute all phases for Qualification and Validation activities:
  • Dry heat oven: chamber and load thermomapping
  • Washing machine: cleaning validation
  • Isolator: VHP, integrity studies and EMPQ
• Supporting engineering, quality, QC and production in a campus-wide validation team.
• May coordinate and oversight of external validation partners.

• MSc degree (or BSc with increased level of experience: 5-7 years) in technical or life sciences
• A minimum of 3-5 years of working experience within pharma company in validation or equivalent position
• Experience working in project teams
• Profound know-how of Validation requirements according to cGMP regulations
• Basic Know-how of QC processes
• Analytical thinking and problem-solving ability