Technical Specialist

Position - Technical Specialist

• Pay Rate: $70K - $80K Base CAD Yearly
• Location: Brockville, ON
  
  

Raise is currently hiring a permanent, full-time team member on behalf of our client. They’re expanding their team to meet growing needs, making this a unique opportunity to work with an industry leader.

Primary Responsibility

This position focuses on manufacturing process and cleaning validation initiatives at Trillium, with significant interaction across equipment and facility qualification activities.

As a member of the Engineering – Technical Services team, the Technical Specialist serves as a subject matter expert (SME) on:

• Formulation characteristics
• Manufacturing processing techniques
• Identification of critical process parameters
• Cleaning and process validation requirements
  
  

The role involves writing and executing qualification protocols for new and modified manufacturing and cleaning processes.

The Technical Specialist will also conduct data analysis, recommend operational process improvements, and assist in establishing cycle times and standards. This is a cross-functional role with regular collaboration across Operations, Technical Services, Quality Systems, Environmental Health & Safety, and interaction with external customer peer groups.

Specific Duties & Responsibilities

• Develop and prepare process and cleaning validation protocols and documentation per master plans and SOPs.
• Execute protocols as prescribed and ensure proper documentation of all validation/qualification activities.
• Coordinate validation activities across departments (QC, QA, Production, etc.) to ensure completion and accurate reporting.
• Prepare and submit final validation/qualification summary reports for review and approval.
• Lead the design and evaluation of formulations and manufacturing processes for solid, semi-solid, and liquid dosage forms during product transfers.
• Lead or support implementation of new technologies, equipment, and processes.
• Plan and manage projects related to new business or changes to existing processes.
• Liaise with internal and external customers to meet project and company objectives.
• Assist in training operators or other staff on validation protocols and SOPs.
• Prepare, maintain, and review validation compliance documentation, including change management.
• Provide technical support and guidance for product transfer activities.
• Collaborate with Program Managers to develop and maintain project timelines.
• Investigate and help resolve process-related problems.
• Ensure all validation activities are efficient and completed on time.
• Prepare pilot or trial batches for development, stability, and investigations.
• Create or revise Standard Operating Procedures (SOPs) related to validation and qualification.
• Support communication with external auditors or regulators as directed by leadership.
• Participate in formal program gate reviews internally and with customers.
• Conduct validation audits to ensure compliance with internal or regulatory requirements.
• Maintain databases or tracking systems for validation activities.
• Identify deviations from standards and recommend corrective actions.
  
  

Requirements

• Bachelor’s degree in Engineering, Chemistry, Pharmaceutical Manufacturing, Industrial Pharmacy, or a related field.
• Minimum 5+ years of experience in a GMP pharmaceutical manufacturing environment.
• Strong knowledge and expertise in validation concepts and risk assessment tools.
• Excellent organizational, time management, and project management skills.
• PMP certification or equivalent is a preferred asset.
• Ability to analyze systems and processes and recommend improvements.
• Strong problem-solving and troubleshooting skills.
• Excellent oral and written communication, including technical reporting.
• Strong interpersonal and teamwork skills.
• Proven ability to collaborate effectively across all levels of the organization.
  

Looking for meaningful work? We can help

Raise is an established hiring firm with over 65 years of experience. We believe strongly in making the world a better place through work, which is why we’re a certified B Corporation and donate 10% of our profits to charity.

We strive to build teams that reflect the diversity of the communities we work in. We encourage all qualified applicants to apply, including people from traditionally underrepresented groups such as women, visible minorities, Indigenous peoples, people identifying as LGBTQ2SI, veterans, and people with visible/nonvisible disabilities.

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