Senior Operations Process Specialist

Position

Vollzeit

Festanstellung

Mid

Operations

Konditionen

Schaffhausen, Switzerland

Anforderungen

5+ J. Erfahrung

Bachelor

EU/EFTA-Bewilligung

Sprachen

Deutsch B2

Englisch B2

Beschreibung

Senior Operations Process Specialist (m/f) The Senior Operations Specialist supports the CM&T Operations organization and the Facility Start‑Up Manager. The role is responsible for executing non‑conformity (NC) and NC/CAPA processes and for supporting F2P2 Next Level start‑up activities. It also provides operational support for new technology implementations, continuous improvement initiatives, and product‑portfolio projects to enable compliant, scalable clinical manufacturing operations.

Aufgaben

Lead investigations into non‑conformities, drive corrective and preventive actions (CAPAs), and verify closure in collaboration with Quality.
Provide operational and technical input and hands‑on assistance for commissioning, qualification, and GMP‑compliant operations.
Support technical assessments and pilot testing, contribute to process validation and SOP/work‑instruction development, and help ensure readiness for transfer to operations.
Collaborate with Quality, Engineering, Project Management and other local functions to resolve start‑up and ramp‑up issues and mitigate operational risks.
Support generation and improvement of required GMP documentation.
Support the technical implementation of New Product Introductions (NPI) in F2P2.
Responsibility for successful aseptic process simulation (APS) with hand-over to operational team.

Anforderungen

Completed vocational training in the pharmaceutical field or a BSc in Pharmaceutical, Biochemical, Chemical, or related Sciences.
At least 5-7 years of professional experience in related activities in the pharmaceutical industry.
Excellent technical understanding of aseptic manufacturing technologies and processes.
Production experience within a GMP regulated environment is mandatory.
Strong knowledge of Annex 1 requirements and contamination control principles in aseptic manufacturing environments.
Excellent interpersonal skills.
Change management skills.
Project leadership experience.
Excellent analytical skills, communication strength, empathy, assertiveness and high customer and business orientation.
Very good level of German and English both spoken and written.
Experience supporting facility start-up, operational readiness, technology transfer, and qualification activities is highly desirable.

Technologien

Good Manufacturing Practices (GMP)Lean Manufacturing PrinciplesLean Supply Chain ManagementRobotic Automation

Vorteile

Multifaceted challenge in a dynamic, international environment.
High technology standards.
Attractive terms.
Excellent infrastructure.

Unternehmen

Johnson & Johnson / Janssen

Pharmaceuticals

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 . 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.