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 2023!
Function Specific Tasks:
- Execute SKAN isolator and related equipment start-up, commissioning, calibration, SIO (set in operation), IQ/OQ testing at customer sites
- 75% percent overnight travel required
- Generate final qualification reports and review results with customers, edit and update for final signature.
- Plan and coordinate documentation (protocols) preparation with SKAN US and SKAN AG resources and customers to be ready for site execution
- Review and coordinate work of SKAN US service technicians for field qualification execution and execute/review completed protocols and reports.
- Prepare and coordinate with SKAN AG project manager to insure readiness of the logistics for IQ/OQ and other testing execution
- Execute isolator equipment and sensor calibrations, HEPA filer certifications and air flow analysis/visualization testing.
- Insure proper operation of environmental monitoring equipment (particle counters and viable air samplers)
- Perform PLC alarm and limits testing
- 2-5 year of experience in equipment validation/qualification, preferably pharmaceutical equipment.
- Hands-on skills for equipment and sensor calibration and testing, plus HEPA filter certification
- Strong written and verbal communication skills.
- Strong computer skills in MS Office Suite and SAP applications
- Good analytical skills and attention to detail to follow protocols and execute/review documents to exacting standards.
- Understanding and awareness of pharmaceutical documentation practices and cGMP manufacturing regulatory environment.
- Minimum 2- year but strongly preferred four year BS in engineering, Engineering Technology or similar degree.
- Previous pharma industry experience preferred (minimum 2-3 years), preferably in aseptic processing.
- Professional attitude, team spirit, handles pressure well and has good written and verbal communication abilities.
- Working knowledge of spoken and written German would be an advantage, but not required.
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
- Major medical, dental and vision for employee and family
- Short-term and long-term disability for employees
- 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 firstname.lastname@example.org