Field Qualification Engineer | Remote

About the role

SKAN is a global leader in pharmaceutical industry cleanroom equipment, used in vaccine development, production of pharmaceutical products, and other critical operations.

Responsibilities

• 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

Qualifications

• 2-5 years 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.

Pay

$71,000 – $95,000

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