\\n anch of Cilag GmbH International is recruiting for a Commissioning and Qualification Engineer, located in Bern, Switzerland:

With this role, you are in charge of commissioning and qualification activities for (new) biopharmaceutical processes in the Technical Services department in order to ensure that:

• Qualification phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities
• Qualification Master plans are up to date and established for all ongoing projects

Key Responsibilities:

• Plan, coordinate and execute all phases for qualification of equipment, utilities and facilities including impact/risk assessment, DQ, IQ, OQ, PQ (end-to-end qualification)
• Prepare, review and approve technical and GMP related documentation (URS, TS, FS, qualification/validation documentation)
• Bridging with cross-functional teams handling preventive maintenance, systems calibration and repair and ensuring system readiness for production
• Coordinating with production, Quality Control, finance, engineering and EHS the commissioning activities for new system and supporting the user in issuing URS and technical documents
• Supporting engineering, quality, production and QC in a campus-wide qualification team during the system life cycle management (from commissioning to decommissioning)
• Oversee and execute FAT/SAT, commissioning activities in collaboration with internal and external partners
• Coordination and oversight of external qualification partners
• Operational handling of Change Controls, CAPAs and Non-Conformances related to process systems and QC lab equipment
• Authoring of work instructions, SOPs and technical presentations
• Contribute to ensure the changes introduced in the organization of systems, procedures and processes are managed so that all aspects of systems life cycle are assessed and achieved
• Propose activities for continuous improvements of the security safeguards and behaviors in line with the business strategy.
• Constantly contribute to cost containment and improvement of standards identifying, proposing and implementing process improvements, rationalization and standardization of processes/products aligned with corporate policies and site objectives established.
• Acting as subject matter expert during inspections and audits
• Facilitates successful team behavior within Quality and across functional areas

Education:

University degree in Engineering, natural or technical sciences or equivalent
Experience and Skills:

• A minimum of 5 years of working experience within pharma or a biotech company
• Profound know-how of Qualification requirements according to cGMP (EudraLex, FDA, WHO)
• Knowledge of current GMP standards and guidelines related to equipment, utilities and facilities qualification (ISO, ICH, FDA, ISPE)
• Basic know-how of biotechnology and QC processes
• Basic know-how on Cleaning and Process Validation
• Know-how of Quality Assurance principles
• Analytical thinking and problem-solving ability
• Team player, self-starter, multitasker and a good time manager

Other:

• Business fluency in English is a must, German fluency is optional
• Integrated Microsoft applications (Windows Professional Office Package)
• Knowledge of Trackwise, SAP and EDMS applications is a plus

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.\\n \\n \\n \\n \\n \\n

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