Technical Specialist

Job Title: Technical Specialist
Location: Cambridge, ON (On-site)
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

•     New Product Introductions

•     CMO technical transfer package development

•     PLCM investigations (post-launch failures / critical issues impacting product manufacture)

•     Procedural and MBR updates impacting critical processing parameters

•     R&D technical transfer projects

•     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 and requirements evolve. 

Competencies Required for the Role

ANALYTICAL THINKING/PROBLEM SOLVING - is the ability to identify the information needed to clarify a situation, seek that information from various sources and then tackle a problem by using a logical, systematic, sequential approach.  Ability to identify and separate the key components of problems and situations.  Ability to interpret information from a range of sources to spot patterns and trends in information and to deduce cause and effect from this.  

THOROUGHNESS/DETAIL ORIENTED – Ensuring that one’s own and others’ work ad information are complete and accurate; carefully preparing for meetings and presentations
following up with others to ensure that agreements and commitments have been fulfilled.

PROCESS IMPROVEMENT – involves the business practice of identifying, analyzing, and improving existing processes to optimize performance.

EFFECTIVE COMMUNICATION - Is the ability to convey information to another effectively and efficiently, to listen – help facilitate sharing of information between people.  It is about understanding the emotional intention behind the information.  The ability to express oneself clearly in conversations, confirm understanding, communicate using data and facts.  Exhibit willingness to listen, and show respect for oneself and others in interactions with others.   express oneself clearly in verbal and business writing.

INITIATIVE - Identifying what needs to be done and doing it before being asked or before the situation requires it.

ADAPTABILITY/ CHANGE AGILITY- remains effective amid shifting priorities, new systems, and organizational growth (acquisitions, new sites, evolving technology); helps others navigate change constructively.

DIGITAL & DATA FLUENCY— comfortable working within electronic quality and manufacturing systems (eQMS/MES) and using data trending/analytics to support decisions, not just paper-based recordkeeping.

Essential

• • Minimum 5 years of related experience.
  • Sterile manufacturing / fill-finish experience required in the pharmaceutical or biotech industry (sterile injectables preferred).
  • University/College degree in an Engineering or Science-related discipline preferred.
  • Advanced knowledge of the operational principles of pharmaceutical manufacturing equipment and processes as they pertain to liquid filling, especially sterile parenteral products.
  • Strong knowledge of project management methodologies and industry best practices.
  • Expert computer skills across Microsoft Office (Word, Excel, PowerPoint, Project, Outlook, and others).
  • Excellent document and report writing and reviewing skills using scientific language.
  • Capable of completing project assignments independently with strong time management, escalating for clarification or decisions as necessary.
  • A team player with excellent conflict resolution skills.
  • Demonstrated interpersonal savvy and relationship management/networking skills, including across sites and geographies.
  • Strong written and oral communication skills in English.
  • Lean/Six Sigma or equivalent continuous improvement training an asset
    
  • Working knowledge of, or willingness to develop proficiency in, electronic quality management systems (eQMS) and statistical/trending software
    

What We Offer

• Competitive salary.
  
• 13 paid holidays.
  
• Competitive vacation policy effective upon hire.
  
• 5 paid personal care days.
  
• Medical, dental, vision.
  
• Employee Assistance Program.
  
• Expected Salary Range: $60,000 - $70,000/Year
  

About Bimeda

Bimeda is a leading global innovator, manufacturer and marketer of veterinary pharmaceuticals and animal health products and has over half a century’s experience in providing science-driven solutions to optimize the health, wellbeing and productivity of the world’s animals. 
 
Bimeda’s global innovation program sees six state-of-the art R&D centers across four continents collaborate on an enviable product development pipeline which anticipates the ever-evolving needs of the animal health industry. 
 
Bimeda’s nine manufacturing facilities across seven countries allow the company to manufacture a broad range of preventative, curative and nutritional products including sterile injectables, vaccinations, nutritional boluses, feed additives, tablets, water-soluble powders, pastes and non-sterile liquids.  
 
Globally, the company focuses on the development, manufacture and commercialization of quality Bimeda-branded products while also being the partner of choice for contract manufacturing and R&D services for prominent companies within the animal health industry. 
 
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More Info atwww.bimedacareers.com