Qualification Engineer in the Drug Substance Area

About the job

Roche Switzerland bridges the gap between pharmacy and diagnostics. Important research and development functions are located here. For our long-standing client, F. Hoffmann - La Roche AG in Basel, we are looking for a

Qualification Engineer in the Drug Substance Area

Background:

Pharma Engineering is seeking suitable candidates with experience both in equipment qualification in the Drug Substance area (API manufacturing) as well as in Computer System Validation (CSV).

The work environment includes process equipment, media, energy, air conditioning such as reactors, fermenters, centrifuges, purified water, steam, autoclaves, cleanrooms as well as the associated controls and process control systems (CSV).

Tasks & Responsibilities:

• Creating concepts, QPP (Qualification Project Plan) or VMP (Validation Master Plan)
• Creating qualification/validation plans/reports for all phases according to Roche quality system
• Performing qualifications/validations in all phases according to Roche quality system
• Assessing technical changes to equipment regarding impact on the qualified state and independently handling requalification activities
• GMP-compliant documentation of performed work and summarising any deviations encountered
• Developing solutions for the deviations encountered
• Familiarising with an electronic qualification and validation software

Must Haves:

• Degree in a natural science/engineering field or relevant professional experience.
• Minimum 3 years of professional experience and solid experience in the qualification process
• Practical professional experience with qualifications/CSV of various types of equipment/systems and rooms/media
• Several years of experience in the GMP area with in-depth understanding of quality systems and lean implementation of GMP requirements
• Good knowledge of the topic "Data Integrity"
• Very good German skills in spoken and written form, good English skills

What is offered to you:

• An opportunity to contribute to one of the world’s most important pharmaceutical companies
• Modern campus with plenty of green spaces and meeting areas
• Varied job profile
• Training opportunities through temptraining
• Working in a dynamic and motivated team

You are welcome to send your complete application documents to Ms Marianne Buser.

Basel Basel-Land Aargau Chemistry VMP QPP CSV GMP Engineer Qualification Engineer