Technical Services Specialist

Job Title: Technical Services 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: We do not use artificial intelligence to screen, assess, or select applicants

Role Summary

The Technical Services Specialist is responsible for developing, implementing and maintaining projects and programs to support the Technical Transfer and Post Commercial Product Lifecycle processes. The projects fall into, but are not limited to, the following categories:  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 and R&D Technical transfer projects.

Key Role Specific Requirements

Demonstrates an advanced level of operational manufacturing knowledge of sterile injectable products and·

Demonstrates a thorough understanding of regulatory guidance requirements particularly as they pertain to requirements governing proposed changes into written documents. Briefs stakeholders and senior management on the implications of regulatory requirements on projects and their timelines.

Delivers effective and accurate project progress reports that can be analysed 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 get all critical activities completed in support of assigned projects and ensures Technical leadership in in overseeing FAT/SAT/IQOQ and PQ activities as they pertain to projects within the scope of the role.

As part of 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. 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 to ensure understanding and repetitive execution on the outcomes of projects being delivered.

Ensures there is a strong safety culture and performance in the execution of projects. Works in compliance with all established Safe Work Practices (SWP) and the company SOPs and operational SOPs that enforce them. Understands the requirements and responsibilities for Environmental, Health & Safety and ensures that these applied. 

Communicates and builds relationships with all levels within the company. Presents solutions and solicits feedback from management and stakeholder groups.

Organises, chairs and reports on meetings held to resolve technical and operational issues within scope of role.

Utilise open, honest, two-way communication to build trust-based relationships with employees, business partners and direct leader while continuously improving leadership capabilities by personally seeking feedback and development.

Adheres with 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.

Essential

Minimum 5 years related experience

University/College Degree in Science related discipline (Microbiology, Biochemistry, Chemistry, Pharmaceutical Sciences, Biochemical Engineering)

Knowledge of the operational principles of pharmaceutical manufacturing equipment and processes as they pertain to sterile parenteral products.

Strong computer skills for Microsoft Office (Teams, Word, Excel, Powerpoint, Project, Outlook and others).

Excellent document and report writing and reviewing skills using scientific language, capable of conveying information and proposals logically, clearly and unambiguously.

Capable of completing project assignments independently and with good time management, escalating for clarification or decisions as necessary

Strong written and oral communication skills in English

A team player with excellent conflict resolution and leadership skills

Demonstrated interpersonal savvy and relationship management/networking skills

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: $90,000 - $110,000/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