Job Title: Production Support Specialist

Location: Cambridge, ON (In-Office)

Position Type: Full-time regular

Shift: Day 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
Reporting to the Plant Manager, the primary role and tasks for the Production Support Specialist is to perform and coordinate all aspects of investigations of production/manufacturing related incidents and deviations to ensure compliance with pharmaceutical products manufacturing regulations and cGMP. A detail-oriented individual will conduct root cause investigations, close deviations on time, support assignment of proper corrective actions, and facilitate the implementation of corrective actions for manufacturing and operating processes. Using a hands‑on approach, the specialist actively executes the deviation investigations, effective and efficient investigation writing, corrective and preventive actions development & implementation with production and supporting stakeholders. The Specialist will work closely with all in compliance with current FDA and Health Canada regulations, cGMP and GDP practices. Participation in Regulatory Agency inspections/activities required as needed.

Key Role Specific Requirements
Deviation Investigations & Writing

Work directly with production and quality teams on the manufacturing floor to collect and collate all required information, data and facts at the point of issue and deviation occurrence.

Meet and exceed performance and deliverable expectations of completing investigations and writing investigations on time as laid out by the plant manager.

Review batch documentation, testing results, training records, calibration records, policies, standard operating procedures, regulatory policies, testing and manufacturing specifications, validation documents, and other technical documents to support the deviation investigations and writing.

Lead the investigation closure of manufacturing compliance‑related documents using quality and statistical tools to identify and implement proper corrective and preventative actions to manufacturing non‑compliance on time.

Write deviations investigations using the right writing and compliance practices. Writing should be SMART – Specific & Situational, Measurable & Methodical, Actionable & Accurate, Realistic and Timely.

Continuous Improvement

Engage and perform deviation investigations process by understanding the current state of process, sequence of flow, breaking down the problem into what, where, when, who, how: determine the point of cause,



analyze and determine the real root causes by using various problem solving tools – Cause and Effect, 6M-Fishbone Analysis, 5 Why, Pareto and Graphical Analysis, Process Capability Methods; and Right Countermeasure Development.

Use A3‑8 Step problem solving methodologies to facilitate investigations. Work with production and supportive stakeholders to determine possible countermeasures for CAPAs.

Training

Deliver focused training programs designed to enable staff to consistently execute all manufacturing processes with strict compliance to cGMPs, EHS regulations and any other CAPA improvements related training.

Identify and implement process improvements to drive success in the areas of quality, compliance, throughput flow, workplace safety, cost‑effectiveness, and product lead time through CAPAs.

Keep current with new guidelines and Health Canada and FDA inspectional and scientific trends; and adjust CAPA procedures appropriately.

Work with management team to improve the quality of the process and the procedures.

Any other tasks and 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

EFFECTIVE COMMUNICATION – Ability to convey information effectively, listen, and share information between people; express oneself clearly in conversations, confirm understanding, communicate using data and facts; exhibit willingness to listen and show respect.

ANALYTICAL THINKING/PROBLEM SOLVING – Ability to identify necessary information, seek it from various sources, and tackle a problem using a logical, systematic, sequential approach; identify key components of problems; interpret information from a range of sources to spot patterns and trends and deduce cause and effect.

THOROUGHNESS/DETAIL ORIENTED – Ensure complete and accurate work; prepare carefully for meetings and presentations; follow up to ensure agreements and commitments are fulfilled.

PLANNING – Ability to think about and organize activities to achieve desired goals.





CHANGE AGILITY/ADAPTABILITY – Ability to support innovation and organizational changes, initiate, sponsor, and implement changes; embrace change and strive for continuous improvement.

Essential

3-5 years of prior experience in an aseptic manufacturing environment.

Training and knowledge of Good Manufacturing Practice regulations and standards.

Bachelor’s Degree in Life Sciences, Microbiology, or equivalent degree/diploma.

Direct knowledge of cGMP regulations.

Ability to develop, review, and maintain metrics and quality audits.

Ability to prioritize and manage multiple tasks to demanding deadlines.

Ability to interface directly with cross‑functional teams.

High level of personal motivation.

Extremely detail‑oriented and analytical thinker with strong problem‑solving ability.

Excellent written and verbal communication skills.

Proven ability to build robust working relationships, internal and external to the organization.

Desirable

Investigations experience in sterile manufacturing, filling & packaging environment.

Prior experience in Fishbone Investigation Procedure and A3 problem solving technique.

Compensation & Benefits

Competitive salary.

13 paid holidays.

Competitive vacation policy effective upon hire.

5 paid personal care days.

Employee Assistance Program.

Medical, dental, vision, STD & LTD benefits.

Expected Salary Range: $65,000 - $75,000 / Year, DOE.

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

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📌 Production Support Specialist (Ontario)
🏢 Bimeda
📍 Ontario