Process Engineer PAR NPI/LCM

8562-Cilag AG Legal Entity; Schaffhausen; Vor Ort; CHF 120.000 - 160.000; Vollzeit

Zusammenfassung

Johnson & Johnson is hiring a Staff Process Engineer for Parenterals NPI & Life Cycle Management to drive the transfer of new products into commercial production. You’ll implement new processes and ensure robust, compliant manufacturing in collaboration with MSAT and Operations.

Responsibilities include leading engineering runs, supporting inspections and regulatory filings, and solving complex process challenges in filling operations, with emphasis on continuous improvement.

Qualifikationen

• 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 and knowledge of site systems (SAP/PAS-X).

Aufgaben

• 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 with Operations, Engineering, and MSAT.
• Lead and support improvement projects to 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 on project-related content and process changes.
• Serve as SME in project-related audits and inspections.
• Collaborate closely with Production and other partners to ensure aligned implementation.
• Follow GMP, EHS, and SOX guidelines.

Kenntnisse

Agile Manufacturing

Analytics Dashboards

GMP

Process Optimization

Problem Solving

Data Savvy

Data Compilation

Communication

Project Administration

Mentorship

Ausbildung

Bachelor’s degree in natural sciences or engineering

Master’s degree preferred

Tools

SAP

PAS-X

Jobbeschreibung

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

Job Function: Supply Chain Manufacturing
Job Sub Function: Manufacturing Pharmaceutical Process Operations
Job Category: Professional
All Job Posting Locations: Schaffhausen, Switzerland

Job Description

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine. 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.

Required Skills

• Agile Manufacturing
• Analytics Dashboards
• Business Behavior
• Chemistry, Manufacturing, and Control (CMC)
• Communication
• Competitive Landscape Analysis
• Data Compilation
• Data Savvy
• Gap Analysis
• Good Manufacturing Practices (GMP)
• Industry Analysis
• Mentorship
• Operational Excellence
• Plant Operations
• Problem Solving
• Process Optimization
• Project Administration
• Technical Credibility

Preferred Skills

• Agile Manufacturing
• Analytics Dashboards
• Business Behavior
• Chemistry, Manufacturing, and Control (CMC)
• Communication
• Competitive Landscape Analysis
• Data Compilation
• Data Savvy
• Gap Analysis
• Good Manufacturing Practices (GMP)
• Industry Analysis
• Mentorship
• Operational Excellence
• Plant Operations
• Problem Solving
• Process Optimization
• Project Administration
• Technical Credibility

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 Section503 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.