Operations Technician - BioServices

POSITION SUMMARY

The Operations Technician - Bioservices role is responsible for ensuring all operational activities are executed accurately and timely, following specific procedures and processes as defined in Work Instructions. This Operations Technician- Bioservices role involves the production of various types of material kits, label printing, kits packaging and labelling, cleanroom cleaning, environmental monitoring, material transfer from warehouse to cleanroom and related documentation completion.

PRIMARY RESPONSIBILITIES (include but are not limited to)

• To perform material transfer, material kits production, kits labeling and packaging, batch records completion, cleanroom cleaning, monitoring, labels printing according to standard operating procedures.

• Assemble a range of kit types according to strictly defined client specifications.

• Liaising with Program Managers to provide support with the scheduling of work, assisting in writing and updating SOPs, and other project-related activities.

• To assist in deviation investigations and change control documentation.

• Scheduling of project work, accounting for deadlines, available resources, and business need.

• Disseminating information from and providing feedback to Project Managers.

• Ensure material availability in the cleanroom for kit production, packaging, and labeling.

• Assists with Quality assurance tasks such as verification, validation and calibration procedures as required.

• Ensures project work areas are kept clean and free of any possible safety hazards.

• Understands and uses the inventory management, temperature monitoring, and site infrastructure systems.

• To be available for infrequent overtime work as necessary and to be willing to attend site, out of hours in the case of emergency or extraordinary work requirement.

• Documents alarms in response to the environmental monitoring systems (EMS).

• Works around hazardous substances and follows all safety guidelines to minimize exposure.

• Assures compliance to cGMP requirements and company quality systems.

• Maintains training records and participates in staff quality training

• Ensures all job-related paperwork is correct, error-free, and completed in real-time as per SOPs.

• Ensures strict client confidentiality at all times.

• To participate and contribute to operational excellence and process improvement projects that cost-effectively deliver the business objectives.

• Assist in the supervision of temporary contract staff as required.

• To participate in client audits and facility presentations as needed.

• To effectively communicate to ensure all project related information is conveyed in a timely and comprehensive manner.

• Perform project/task-specific training as required.

• When needed, be the back-up of the cryopreservation operations team

COMPETENCIES & PERSONAL ATTRIBUTES

• Exhibit professional behavior, language, and appearance at all times.

• Follows policy when escorting client sponsors through the facility, is courteous, and displays a positive attitude.

• Maintains a professional manner when problems/conflicts arise.

• Good understanding of quality management.

• Previous experience working with materials kitting and cleanroom environment is desirable.

• Flexible and adaptable with excellent interpersonal skills (at all levels)

• Able to analyze problems and define solutions.

• Attention to detail  (right-first-time) mentality.

• Able to work under pressure and to support others within the team.

• Builds customer commitment.

• Supports operational excellence (30/30)

• Focus on priorities (80/20)

• Teamwork, collaboration, and accountability (90/10)

• Emphasis on business growth.

• Passion for and alignment with Cryoport mission.

• Professional English skills is a plus

• Fluent in French

QUALIFICATIONS AND EDUCATION REQUIREMENTS

• Secondary school diploma.

• Minimum 1-2 years experience working in a GMP / GxP environment.

• Hands-on experience working with material kitting is desirable.

• Hands-on experience working in cleanroom environment.

• Proficient in computer skills, specifically with Microsoft Office Suite.

• Experience working in a contract development or manufacturing environment is a plus.

• Frequently required to type, sit, stand, walk, lift/carry up to 20kg (with support).

• Occasionally required to push/roll 30kg liquid nitrogen dewars and work from a platform ladder.