Senior Scientist QC Bioanalytics (m/w/d) 80-100%

Lonza; Lavamünd; Vor Ort; Vertraulich; Vollzeit

Zusammenfassung

Lonza in Visp, Switzerland, seeks a Scientist (m/f/d) to join the Quality Control team. You will execute routine biochemical methods such as ELISA, qPCR and enzyme assays in a GMP environment, ensuring data integrity and regulatory compliance.

You will collaborate across QA, QC, IT and QUS teams, maintain instrument qualification data, and uphold CSV and ALCOA+ standards while advancing process improvements.

Qualifikationen

• Bachelor or Master in science or equivalent.
• Solid experience with quality control laboratory instruments.
• GMP experience in the pharmaceutical industry is a must.
• Good knowledge of AIQ and CSV concepts.
• Solid English communication skills.

Aufgaben

• Prepare qualification, calibration, and maintenance plans per GMP and guidelines.
• Validate SMP templates and perform ERAS/DIRAS per procedures.
• Ensure data integrity and proper data storage and backup practices.
• Coordinate with QUS, IT, QA and QC; oversee system validation and changes.
• Understand LIMS interfaces and electronic data capture across platforms.

Kenntnisse

Quality control

Software validation

Data integrity

English communication

Ausbildung

Bachelor/Master in science

Tools

SpectraMax

qPCR

ViaCell

Jobbeschreibung

Location: Visp (Switzerland)

Relocation assistance is available for eligible candidates and their families, if needed.

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of!

At the Visp site, we are looking for a Scientist (m/f/d). As a member of our great Quality Control team, you will be responsible for the routine execution of various biochemical methods, focusing on ELISA, qPCR, ProA and enzyme assays, while adhering to GMP and safety guidelines.

What you'll get:

• An agile career and dynamic working culture
• An inclusive and ethical workplace
• Compensation programs that recognize high performance
• Along with competitive salaries, you'll find a wide range of lifestyle, family and leisure benefits available. The full list of our local benefits can be also found on assetstream.aspx

Key responsibilities :

• Preparation of qualification, calibration, maintenance plans in line with GMP and regulatory requirements. (IQ, OQ, PQ) according to guidelines and procedures. Verify proper installation of instruments (SpectraMax, qPCR, ViaCell etc.) according to manufacturer specifications and GMP standards.
• Validation of SMP Templates
• Performing ERAS and DIRAS according guidelines. Ensure all qualification data is accurate, complete, secure, and compliant with data integrity principles
• Ensuring communication with the responsible QUS, IT, QA and QC employees. Awareness of software lifecycle management, including validation, updates, patches, and version control, ensuring continued compliance with GMP requirements.
• Knowledge of electronic data capture, storage, backup, and retrieval processes to ensure compliance with data integrity principles (ALCOA+). Ability to interpret system logs, error messages, and diagnostic tools to identify and resolve software or hardware issues during maintenance and qualification
• Ensure ongoing compliance with GMP through audits and continuous process improvements. Familiarity with regulatory guidelines relating to computerized systems in GMP environments, such as FDA 21 CFR Part 11 and EU Annex 11.
• Understanding of how instruments/robots interface with Laboratory Information Management Systems (LIMS) or other relevant platforms.

Key requirements:

• Bachelor/Master in science or equivalent
• Solid experience with quality control laboratory instruments (e.g. SpectraMax, qPCR, ViaCell)
• Solid experience in the pharmaceutical industry in a GMP environment is a must
• Good knowledge of analytical instrument qualification (AIQ), as well good background of CSV (computer system validation)
• Experience and understanding with software, IT programs
• Structured, focused and well-organized working attitude. Open-minded for new ideas and suggestions, highly motivated and dynamic drive. Teamwork, as well flexibility for various tasks in technology team
• Good verbal and written communication in English

Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.