Description
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.
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Job Function:
Supply Chain EngineeringJob Sub Function:
Process EngineeringJob Category:
Scientific/TechnologyAll Job Posting Locations:
Schaffhausen, SwitzerlandJob Description:
We are searching for the best talent for Senior Engineer, MSAT Biotherapeutic Drug Product (24 month fixed-term contract)! This hybrid position will be located in Schaffhausen, Switzerland.
As a member of the Site Technical Owner (STO) Team, the Senior MSAT Bio DP Engineer will serve as the Site MSAT representative on multi-functional teams and is responsible for leading the reliability of product processes of commercial product and new product introductions (NPI's) for biologic parenteral liquids, suspensions, and lyophilized products at the Schaffhausen Fill Finish site. This involves collaborating in multi-functional teams within the site and exchanging knowledge with other locations worldwide. They will provide technical support and leadership to top-line growth, as well as ensure reliability, compliance, and efficiency of product value chains end-to-end (E2E). The Site MSAT Rep will also integrate Manufacturing Operations and Pharmaceutical Development, in partnership with Product and Customer Management.
Responsibilities:
Serve as Site Technical Owner for specific commercial drug products in Life Cycle Management
Own and coordinate validation activities with internal partners
Lead or contribute to multi-functional project teams, providing technical guidance and coordinating activities to meet quality, timeline, and compliance objectives
Implement process capability, quality, and cost improvement changes
Support E2E technical guidance for product lifecycle activities, including Continued Process Verification (CPV) trending, change implementation, and continuous improvement
Provide technical feedback and assessments for deviations, investigations, CAPAs, and change controls related to drug product manufacturing processes
Active participation in internal, customer, and health authority inspections as lead Subject Matter Expert
Maintain excellent and collaborative relationships with all business partners
Perform statistical analyses on production data
QUALIFICATIONS:
EDUCATION:
Minimum of a Bachelor's/University or equivalent degree is required; focused degree in Chemistry, Pharmacy, Engineering, or related field is preferred
EXPERIENCE AND SKILLS:
Required:
Minimum 4 years of relevant work experience
Experience in the Pharmaceutical, Biotechnology, and/or Life Science industry
Demonstrated ability to lead and execute projects, preferably as part of cross-functional teams and/or projects
Strong decision-making and problem-solving competencies, combined with excellent communication and negotiation skills
Flexible, motivated, team-player, open to new ideas and driving innovation
Preferred:
Proven experience supporting GMP manufacturing environments, including change control, lifecycle management activities, and hands-on leadership of GMP investigations
Strong background in drug product manufacturing, MSAT, process validation and tech transfer
Solid knowledge of Quality Assurance, Regulatory Compliance, cGMP requirements, and EHS
Familiarity with statistical or data analysis tools (e.g., Minitab or similar) and use of production or quality data to support process understanding
OTHER:
·Requires proficiency in English (oral and written); basic proficiency in German is strongly preferred
·May require up to 10% domestic and/or international travel
·Requires the ability, through our flexible work policy, to work on-site a minimum of three days each week, with the option for two remote workdays each week
Why join Johnson & Johnson
A multifaceted challenge in a dynamic, international environment with attractive terms and career opportunities as well as a good infrastructure at the J&J Innovative Medicine site Schaffhausen.
Many opportunities to work on exciting projects and assignments in a dynamic work environment
A broad spectrum of training opportunities to grow further for personal as well as professional development
The Johnson & Johnson Pension Fund Switzerland offers attractive performance
A range of benefits for insurance, childcare, products, sport, culture and much more
Working at Johnson & Johnson is more than a job. We are changing the trajectory of Human Health and working with Johnson & Johnson can change everything. Including you.
Required Skills:
Preferred Skills:
Agile Decision Making, Coaching, Corrective and Preventive Action (CAPA), Critical Thinking, Emerging Technologies, Issue Escalation, Lean Supply Chain Management, Problem Solving, Process Control, Process Engineering, Product Costing, Product Improvements, Science, Technology, Engineering, and Math (STEM) Application, Situational Awareness, Technical Research, Technologically Savvy, Validation Testing, Vendor Selection