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 welcome several members to the SKAN family in 2022!
- Communicate with SKAN AG about documentation issues
- Create Re-Qualification test protocols and templates report.
- Review executed Re-qualification test reports and forward open punch items to person in charge.
- Support the field service team when required with documentation questions
- Create and distribute accurate and detailed visit reports
- Develop and improve qualification documents and strategies develop and improve qualification documents and strategies
- Communicate status updates with customers and clients
- Provide backup training to technicians when errors are identified
This position is based out of our SKAN US facility in Raleigh, NC. The position reports directly to the Microbiology/Validation and Qualification Documentation Services Manager at SKAN US. The SKAN US Qualification Documentation Specialist may be required to travel to customer locations throughout North America and periodically to SKAN AG, in Basel, Switzerland. The travel requirement is estimated at 10-15% during weekdays and will include some initial weekend travel when training in Basel, Switzerland. The travel may be more important at the beginning of employment for training purposes.
- Must be outgoing, professional in appearance, and have the ability to interact and converse with both external customers and internal SKAN Sales, Service, and Technical support personnel.
- Ability to follow SOP’s, follow instructions, with attention to detail and final report generation.
- Strong written and verbal communication skills
- Strong customer focus
- Ability to perform work accurately and independently
- Previous laboratory, pharmaceutical knowledge preferred
- Knowledge and technical expertise related to H2O2 decontamination, cGMP Standards, OSHA requirements, FDA and EU guidance related to aseptic production, USP and EP standards are all very desirable.
- Fluency with MS Office Suite products is required
- Fluent in English. German language fluency is a plus
- Must be able to lift over 35 lbs
Education and experience:
- Bachelor’s degree in mechanical engineering, pharmaceutical technology, chemical engineering or Experienced technician: experience in GMP/technical environment or equivalent experience
- 1 – 2 year experience in GMP documentation and documentation creation, experience with calibration work.
What can we offer you?
- 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
- Monthly car allowance
- Major medical, dental and vision for employee and family
- Short-term and long-term disability for employee
- 401K with 100% company match up to 6% immediately vested
- 15 paid vacation days and nine observed company holidays per year, generous rollover policy
If you have any questions, please contact Tiffany Rusnak via email@example.com