Tech Service Specialist I
Core
Support effective operations of all laboratory systems and equipment to ensure they are validated, calibrated, and maintained in line with GxP and regulatory expectations.
Role type
Quality Control Technical Services Specialist
Builds
Validated and compliant laboratory systems and equipment for pharmaceutical/medical device testing
Domain
Life Sciences / Pharmaceutical Quality Control
Required skills
GMP regulations application, cGxP knowledge, LIMS/CDS operation, analytical equipment operation, technical documentation, lab system qualification, internal/external audit support, stakeholder collaboration
Preferred skills
Pharmaceutical or medical devices industry experience, practical process improvement initiatives, coaching colleagues
Technologies
LIMS, CDS, analytical equipment, safety gowns, PPE
Responsibilities
Lead and support qualification of new equipment and lab systems; Prepare technical documentation including qualification protocols, SOPs, and investigations; Ensure equipment maintenance and calibration are scheduled and performed compliantly; Support lab investigations as SME; Conduct internal audits and support site/regulatory audits; Coach colleagues on lab systems and equipment.
Seniority
Junior to Mid-level, hands-on IC