Implementation Specialist, Life Sciences – Europe

This is a fully remote position, open to applicants in Denmark.

📋 Description

• Strategize deployments around customers' contamination control strategies and change control processes.

• Evaluate site readiness, which encompasses classified areas, airlocks, material transfer routes, doorways, charging, network access, and cycle-running protocols.

• Provide technical documentation for customer change control, including equipment descriptions, UV-C safety data, and risk assessment inputs.

• Assist customer QA teams on-site during IQ/OQ/PQ execution and approval processes.

• Act as the subject matter expert on the robot and disinfection protocols.

• Offer advice to QA and Microbiology on measurement options and supply robot cycle records for validation documentation.

• Address QA inquiries regarding ADIS cycle record generation, storage, and export procedures.

• Train and certify operators in UV-C safety protocols.

• Aid customers in developing SOPs, work instructions, and training documentation.

• Analyze fleet data, troubleshoot operational bottlenecks, and identify opportunities for expansion.

• Inform customers about firmware updates and assist with change assessments.

• Transition accounts to Customer Success at day 90 with all open items, training records, and utilization baselines.

• Convey field insights to Product and Engineering teams.

⛳️ Requirements

• Bachelor’s degree or equivalent practical experience.

• 2 to 4 years of field-based, customer-facing technical experience, preferably in pharma, biotech, or medical device manufacturing.

• Working knowledge of gowning procedures and operations within classified areas.

• Understanding of ISO 14644, EU GMP Annex 1, and good documentation practices as per GMP regulations.

• Experience with IQ/OQ/PQ processes and change control (EU GMP Annex 15 or equivalent).

• Hands-on experience with the deployment or servicing of complex machinery.

• Proficient in troubleshooting hardware and software issues on-site.

• Familiarity with environmental monitoring and cleaning validation practices.

• Strong technical writing skills for SOPs, work instructions, and training records.

• Fluent in English, both written and spoken.

• Willingness to travel 60% of the time, including some weekends.

🏝️ Benefits

• Equal-opportunity and inclusive workplace.

• Application accommodations available upon request.