- Preparation and execution of validation protocols involving facilitates equipment, utilities and associated automation.
- Preparation, review and approval (as required) of SOPs, validation deviations, change control, validation summary reports and associated documentation.
- Assisting management in preparation of updates to Validation Master Plan, Project Plans, Annual Plans, etc.
- Co-ordination of validation activities with team, internal departments, external contractors and suppliers.
- Prepare and deliver cross functional training in validation methodologies, protocols and related procedures to facilitate validation activities.
- Primary point of contact for validation related issues arising during validation activities (including protocol execution).
- Become SME in site Validation Program, company global directives, procedures and other related compliance/regulatory documents.
- Investigation of deviations / non-conformances to determine [potential] impact on product quality, validation status and associated compliance requirements.
- Review and approve Change Management applicable to any system that needs to be qualified.
- Partners with other functional departments to perform deviation root cause analysis and formulate corrective / preventative actions (CAPA).
- Performance of risk and impact assessments associated with validation activities, deviations and changes.
- Provides support to commissioning activities, including review of commissioning plans, procedures, turnover packages etc. (as required).
- Review Commissioning Master Plan to ensure accuracy with established Engineering Guidelines and Specifications.
- Performs final review of test data / reports to ensure conformance with established specifications and related standard operating procedures.
- Provide guidance on validation requirements and expectations to validation engineers, cross functional peers and project teams.
- Represent validation as a subject matter expert (SME) in all project phases (including commissioning and qualification execution).
- Represent the validation program and designated validation activities during inspection by regulatory agencies and Biogen Quality / Regulatory functions.
- Review of technical documents / reports to ensure that validation activities are consistent with current company, industry, regulatory requirements, and current technology.
- Responsible for assigned validation activities. This role will be a junior/mid-level role as a direct support to the Senior Team members
- Provides input and validation guidance to project activities, attends related meetings for project / area / cross-site efforts
- Executes and/or oversees validation activities.
- Minimum Bachelors Degree in an Engineering or Scientific discipline
- 2-5 years experience in a Pharmaceutical manufacturing environment. Direct Experience in Validation role. Large Scale bioharmacutical project experience is desireable. Experience in Manufacturing, Automation or other functional roles would be advantageous.
- Comfortable acting as the validation subject matter expert in cross-functional teams and making technical decisions related to validation.
- Ability to operate in a dynamic working environment, managing and prioritising multiple interrelated tasks and activities.
- Demonstrates flexibility and pragmatism, while ensuring compliance in all activities.
- Thorough knowledge of biopharmaceutical manufacturing processes, equipment and qualification/validation requirments.
- Good understanding of industry regulations and guidelines particularly those relating to facility, utility and equipment validation.
- Strong technical writing and communication skills in English. Fluency in Swiss Languages are an advantage.
- Knowledge of DCS, MES or PLC systems is an advantage.
- Competent and experienced in Risk Based approaches to Commissioning and Qualification.
- Ability to take the initiative with minimal supervision.
- Particularly Knowledgable on one or more of the following: Upstream Processing, Downstream Processing, Clean Utilties, Computer System Validation.
The role is responsible for writing, performance and reporting on validation activities related to biopharmaceutical Facilities, Utilities, Equipment (FUE) and associated systems (e.g. automation). The individual shall be responsible for planning, coordination and driving validation activities from initiation to successful completion. The individual shall be responsible for their assigned validation tasks, including deviation investigations, risk / impact assessment, etc.
The position requires the ability to communicate effectively with multiple disciplines and people at all levels across the organisation and third parties.
The position will have global as well as local contacts and will be required to make compliance decisions impacting the company.
Works with senior team members over time to become an expert on general validation principles, deviation resolutions, and biopharmacuetical processes.