Process Validation Microbiologist

About the role

SKAN US, Inc., a world leader in pharmaceutical isolators, is seeking a Process Validation Microbiologist to join their team in Raleigh, NC. This position is based at the SKAN US facility and reports to the Director of Process Validation Microbiology.

Responsibilities

• 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
• Microbiological (Re) Qualification of standard isolators
• 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&ID
• Travel up to 50-70%

Requirements

• 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

Qualifications

• Salary Range: $60,000 – $70,000

Benefits

• 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

Pay

• $60,000 – $70,000

Schedule

• Varies