Technical Service Specialist

Job Title:

Technical Specialist

Location:

Cambridge, ON (On-site)

Position Type:
Full-time, regular

Shift: Monday
- Friday

Vacancy Status:
This role is currently vacant

AI Disclosure in Hiring:
Artificial intelligence (AI) may be used to assist with certain aspects of the recruitment process, including the initial review and screening of applications. Final hiring decisions are made by Human Resources and hiring managers.

The Technical Services Specialist develops, implements, and maintains projects and programs supporting the Technical Transfer and Post-Commercial Product Lifecycle Management (PLCM) processes at the Cambridge site. As Bimeda continues to expand its global manufacturing network and modernize its quality systems, this role plays a growing part in keeping technical transfer and lifecycle activities scalable, data-driven, and consistent across the organization. Project categories include, but are not limited to:

• Line transfers and batch scale changes
• New Product Introductions
• CMO technical transfer
• PLCM activities and projects impacting product manufacture
• Procedural updates impacting critical processing parameters
• R&D technical transfer projects
• Cross-site standardization and knowledge sharing contributing technical transfer learnings and best practices to Bimeda's broader manufacturing network as the company scales.

• Demonstrates an advanced level of operational manufacturing knowledge of sterile injectable product
• Demonstrates a thorough understanding of regulatory guidance requirements, particularly as they pertain to proposed changes in written documents; briefs stakeholders and senior management on the implications of regulatory requirements for projects and timelines.
• Delivers effective and accurate project progress reports that can be analyzed and understood at all levels within the organization; utilizes advanced statistical tools for analyzing process data from investigational trials, commercial manufacturing batches, and Design of Experiments.
• Drives all relevant functions to complete critical activities in support of assigned projects, and ensures technical leadership in overseeing FAT/SAT/IQOQ and PQ activities within the scope of the role.
• As part of the PLCM product investigations process, proposes appropriate non-standard testing to progress investigations and evaluations.
• Supports environmental monitoring programs, reviews trends, recommends and implements corrective actions, and ensures compliance with cleanroom standards and regulatory expectations.
• Delivers all required document updates (SOP, M , deviations, specifications, etc.) as required for the project and investigation work being conducted.
• Works closely with the Competency Development group to tailor training programs and simulations, ensuring understanding and repeatable execution on the outcomes of delivered projects.
• Ensures a strong safety culture and performance in the execution of projects; works in compliance with established Safe Work Practices (SWP) and company/operational SOPs; understands and applies EHS requirements and responsibilities.
• Communicates and builds relationships with all levels within the company; presents solutions and solicits feedback from management and stakeholder groups.
• Organizes, chairs, and reports on meetings held to resolve technical and operational issues within the scope of the role.
• Uses open, honest, two-way communication to build trust-based relationships with employees, business partners, and direct leadership, while continuously improving leadership capability through feedback and development.
• Contributes to digital quality initiatives, including participation in electronic quality/manufacturing system adoption and use of data trending…