Staff Process Engineer PAR NPI/LCM

Johnson & Johnson Innovative Medicine; Schaffhausen; Vor Ort; CHF 110.000 - 170.000; Vollzeit

Zusammenfassung

Johnson & Johnson Innovative Medicine in Schaffhausen seeks a Staff Process Engineer Parenterals New Product Introduction & Life Cycle Management to lead the transfer of new products into commercial parenteral production and to implement new technologies in line with technology transfer plans.

You will support process improvements, regulatory filings, and inspections as the subject matter expert, collaborating with Operations, Engineering, and MSAT to ensure robust, compliant production.

Qualifikationen

• Bachelor’s degree in natural sciences or engineering required; master preferred.
• 4+ years in pharmaceutical industry, with 2+ years in parenteral manufacturing or development.
• Experience introducing parenteral products into manufacturing sites.
• Knowledge of late-stage development and manufacturing unit operations (filling, compounding, milling).

Aufgaben

• Act as core team member in technology transfer projects.
• Prepare and execute engineering runs, clinical batches, and validation batches.
• Lead improvement projects to enhance robustness and compliance.
• Manage change controls, recipes, and document updates.
• Train shop floor and leadership on project content and process changes.
• Serve as SME in audits and inspections.
• Collaborate with Production and other partners for aligned implementation.
• Follow GMP, EHS, and SOX guidelines.

Kenntnisse

Agile Manufacturing

CMC

Communication

Cost-Benefit Analysis

Critical Thinking

Data Analysis

Gap Analysis

GMP

Industry Analysis

Mentorship

Operational Excellence

Pharmaceutical Industry

Plant Operations

Problem Solving

Process Optimization

Program Management

Project Administration

Ausbildung

Bachelor's degree in natural sciences or engineering

Master's degree preferred

Tools

SAP

PAS-X

Equivalent systems

Jobbeschreibung

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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.

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:

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

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