Senior Engineer, MSAT Biotherapeutic Drug Product

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

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 Engineering

Job Sub Function:

Process Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Schaffhausen Switzerland

Job Description:

Senior Engineer MSAT Biotherapeutic Drug Product (PG26)

About Innovative Medicine

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 are searching for the best talent for Senior Engineer MSAT Biotherapeutic Drug Product (DP)! 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 (NPIs) 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 NPI Tech Transfer Projects and specific commercial products
• Serve as Subject Matter Expert for Optical inspection related processes e.g. Defect Trending Limit Recalculation
• 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 Bachelors/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 tech transfer and optical inspection related topics
• 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

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

Required Experience:

Senior IC

Employment Type : Full-Time
Experience: years
Vacancy: 1