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Job Function:

Supply Chain Manufacturing

Job Sub Function:

Manufacturing Pharmaceutical Process Operations

Job Category:

Professional

All Job Posting Locations:

Schaffhausen, Switzerland

Job Description:

As Staff Process Engineer Parenterals New Product Introduction & Life Cycle Management, you are responsible for introducing new products into commercial production and implementing new technologies and processes in line with technology transfer plans and business objectives. You support innovation, cost improvement, and compliance projects within parenterals operations and ensure robust, reliable process implementation in close collaboration with operations teams. In addition, you support inspections, regulatory filings, and health authority responses as the subject matter expert for production-related topics.

The role focuses on drug product filling processes.

Key Responsibilities:

• Act as a core team member in technology transfer projects for the commercialization of new products.

• Prepare and execute engineering runs, clinical batches, and validation batches in close collaboration with Operations, Engineering, and MSAT.

• Lead and support improvement projects that strengthen process robustness, compliance, and operational performance.

• Manage change controls, recipes, and document updates related to assigned projects and processes.

• Train shop floor teams and leadership teams on project-related content and process changes.

• Serve as subject matter expert in project-related audits and inspections.

• Collaborate closely with Production and other relevant business partners to ensure aligned implementation.

• Follow applicable GMP, EHS, and SOX guidelines.

Qualifications

Required:

• Bachelor’s degree in natural sciences or engineering is required; a master’s degree is preferred.

• Preferably 4+ years of experience in the pharmaceutical industry, including at least 2 years in parenteral or pharmaceutical manufacturing or development.

• Experience introducing parenteral products into manufacturing sites is preferred, including products with biotechnologically produced and/or chemically synthesized APIs.

• Knowledge of late-stage development activities and manufacturing site unit operations, such as compounding, milling, and filling of liquid formulations and suspensions.

• Strong planning and logistics skills to integrate drug product deliverables and execution at the manufacturing level.

• Knowledge of manufacturing site systems and procedures, such as SAP, PAS-X, or equivalent systems.

• Excellent written and verbal communication skills, with the ability to influence partners, peers, and collaborators at all levels.

• Proficiency in German and English is required.

• Ability to work independently and apply proven problem-solving skills.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

 

 

Required Skills:

 

 

Preferred Skills:

Agile Manufacturing, Business Behavior, Chemistry, Manufacturing, and Control (CMC), Communication, Cost-Benefit Analysis (CBA), Critical Thinking, Data Analysis, Gap Analysis, Good Manufacturing Practices (GMP), Industry Analysis, Mentorship, Operational Excellence, Pharmaceutical Industry, Plant Operations, Problem Solving, Process Optimization, Program Management, Project Administration