Job Description

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.

Role Summary

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.

Key Role Specific Requirements

• 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, MBR, 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 tools to support investigations and technical transfers.
• Adheres to all compliance programs and 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

FOSTERING COLLABORATION/TEAMWORK- is the ability to work jointly with others or together especially in an intellectual endeavor; the ability and desire to work cooperatively with others on a team; as a team leader, the ability to demonstrate interest, skill, and success in getting groups to learn to work together. Builds partnerships for global performance. Respects others.

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.

CREATIVITY AND INNOVATION - is the ability to create, develop and implement a new product, process or service with the aim of improving efficiency, effectiveness or competitive advantage. Also, the ability to transcend traditional ideas, rules, patterns, relationships, or the like, and to create meaningful new ideas, forms, methods, or interpretations.

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.

DEALING WITH AMBIGUITY – The ability to be comfortable with change and uncertainty. The ability to deal with fuzzy problems with limited data and with no clear solutions. The ability to juggle several projects or to not bring closure to one project because of business changing needs.

DIGITAL & DATA FLUENCY — comfortable working within electronic quality/manufacturing systems (eQMS/MES) and using data trending and analytics to support technical and investigational decisions.

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

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: $75,000 - $85,000/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 at www.bimedacareers.com