Job Title: Technical Specialist
Location: Cambridge, ON (In office)
Position Type: Full-time, regular 24 Month Contract

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.

Role Summary

The Technical Specialist is part of the Technical Operations team, responsible for ensuring the Cambridge site executes on its key strategic projects and initiatives from line transfers and batch scale changes through to New Product Introductions, CMO technical transfer packages, and post-launch investigations. As Bimeda continues to grow through acquisition, facility expansion, and an increasingly global manufacturing network, this role is central to keeping technical operations scalable, standardized, and audit-ready across sites.

Core scope includes:

- Line transfers and batch scale changes
- PLCM investigations (post-launch failures / critical issues impacting product manufacture)
- Procedural and MBR updates impacting critical processing parameters
- Cross-site knowledge transfer and standardization supporting alignment of processes, documentation, and lessons learned across Bimeda's global manufacturing network as the company scales
- Digital and data-driven quality initiatives contributing to the ongoing shift from paper-based to electronic quality and manufacturing systems (eQMS/MES), including data trending and analytics

The Technical Specialist also provides project support focused on documentation, process updates, data analysis for yield improvements and batch scale changes,



technical engineering projects, and technical transfer projects building the bridge between R&D; lab development and the technical transfer process and supporting post-commercial remediation and continuous improvement initiatives across the site and, increasingly, across Bimeda's broader manufacturing footprint.

Key Role Specific Requirements

- Demonstrates operational knowledge of sterile and non-sterile products and their manufacturing processes to add value to project execution, evaluations, and recommendations.
- Consults with vendors, equipment suppliers, clients, third-party consultants, contractors, and other stakeholders to understand user requirements and ensure they are incorporated into equipment, process, and facility design as part of assigned projects.
- For assigned projects: researches and develops requirements through engagement of key stakeholders, proposes and justifies approach, and successfully project-manages the solution while adhering to cost, quality, compliance, safety, and delivery targets.
- Demonstrates a thorough understanding of regulatory guidance requirements; accurately incorporates regulatory requirements into written documents; briefs stakeholders and senior management on the implications of regulatory requirements for projects and timelines.
- Delivers effective,



accurate project progress reports that can be understood at all levels of the organization; utilizes statistical tools to analyze process data from investigational trials, commercial manufacturing batches, and Design of Experiments.
- Leads the PLCM product investigation process end-to-end within the timelines required by the business.
- Supports operations in resolving EER (Environmental Excursion) investigations, identifying opportunities to improve processes and prevent recurrence.
- Drives cross-functional teams to complete critical project activities; provides technical leadership to operations and oversees IQ/OQ/PQ activities as required.
- Delivers required document updates (SOPs, MBRs, deviations, specifications) for assigned projects and investigations, and helps facilitate related training.
- Maintains a strong safety culture in the execution of all projects, working within established Safe Work Practices and company/operational SOPs; understands and applies EHS requirements and responsibilities.
- Organizes, chairs, and reports on meetings held to resolve technical and operational issues within the scope of the role.
- Builds trust-based relationships with employees, business partners, and leadership through open, two-way communication, while continuously developing personal leadership capability.
- Adheres to all compliance programs, company policies, and procedures.
- Other duties as assigned.

Please note that this job description is not exhaustive and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities

📌 Technical Specialist 24 Month Contract (Cambridge)
🏢 Bimeda
📍 Cambridge