Process Validation Microbiologist

SKAN US, Inc., a world leader in pharmaceutical isolators, based in Raleigh, NC is accepting applications for the position of Process Validation Microbiologist. This position is based out of our SKAN US facility in Raleigh, NC. The position reports to the Director of Process Validation Microbiology at SKAN US.

SKAN, headquartered in Switzerland with a strong US presence, is a global leader in the pharmaceutical industry for its cleanroom equipment. This equipment is routinely used in vaccine development, production of pharmaceutical products, and other critical operations to ensure the safety and quality of pharmaceutical drugs.

Our US base is comprised of a parts business, a field service/assembly team, a microbiology team, a documentation qualification department, and a field qualification team, among other administrative functions.

SKAN is experiencing rapid growth and is looking forward to welcoming several members to the SKAN family!

• Bachelor’s degree in biology, related science or similar degree or work experience
• Basic training in microbiology, chemistry, scientific understanding
• Interest in technical knowledge
• Knowledge of Pharmaceutical industry
• Laboratory experience
• Driver’s license required
• GMP basics
• Communication in English mandatory
• Communication in German a plus

• cGMP documentation
• Gowning in an aseptic environment
• Understanding of procedures related to task
• Understanding of process to be qualified
• Understanding of documentation
• Placement and evaluation of biological indicators and chemical indicators
• Definition of loading pattern and worst-case position
• Transfer and incubation of biological indicator
• Performance of Microbiological (Re) Qualification of standard isolators
• Performance of Cycle development basic and extensive for standard isolators
• Support for qualification level II or III during a complex or intensive project and tasks
• Handling of non-conformity
• Reporting of work activities in the SAP system
• Use of Profile and Consense
• Understanding of alarm matrix and P&
• Travel up to 50-70%
• Salary Range: $60,000 – $70,000

• An open corporate culture and teamwork
• Short decision-making paths and flat hierarchies
• Intensive orientation and training programs through our SKAN Academy
• Excellent base salary with potential annual bonus opportunity
• Major medical, dental and vision for employee and family
• Short-term and long-term disability for employees
• Paid parental leave
• 401K with 100% company match up to 6% immediately vested
• 15 paid vacation days (minimum) and nine observed company holidays per year, generous rollover policy

If you have any questions, please contact our HR responsible via us.jobsn.ch