Validation Specialist

Kedrion Biopharma GmbH; Laval; On-site; CAD 70,000 - 90,000; Full time

Job summary

A biotechnology company in Laval is seeking a Validation Specialist to ensure compliance with global health authority standards. The role involves managing validation projects, authoring protocols, and providing expertise on validated systems. Candidates should have a relevant bachelor’s degree and over 5 years of validation experience in a pharmaceutical environment. Strong communication skills in English and French are essential.

Benefits

Competitive salary and benefit package

Casual environment

Start-up culture that values autonomy and innovation

Qualifications

• Over 5 years of experience in validation within a pharmaceutical manufacturing or quality assurance environment.
• Proficiency in both English and French.
• Exceptional attention to detail and analytical thinking.

Responsibilities

• Manage validation projects according to timelines and the Validation Master Plan.
• Author and execute cleaning and shipping validation protocols.
• Provide technical expertise to system users for validated equipment.

Skills

Validation expertise

Excellent communication skills in English and French

Technical writing skills

Organizational skills

Problem-solving abilities

Education

Bachelor’s degree in engineering, biotechnology, chemistry, or microbiology

Tools

Microsoft Office (Word, Excel, Outlook)

Job description

Located in the heart of the Cité de la Biotech in Laval, Kedrion Biopharma Canada's mission is to make rare connections that impact millions of lives. Our team is developing an innovative treatment based on plasma-derived proteins, offering a new path of hope to children and adults suffering from orphan diseases. We turn innovation into real solutions to save lives.

Are you ready to put your validation expertise to work in a fast-paced and highly regulated environment? Join Kedrion Biopharma . as a Validation Specialist , and play a key role in ensuring the qualification of our critical systems, equipment, and processes, in compliance with global health authority standards.

More specifically, you will be responsible for :

• Manage validation projects according to timelines and the Validation Master Plan.
• Author, execute, and approve cleaning and shipping validation protocols, as well as IQ, OQ, PQ, and RQ protocols.
• Participate in the design, evaluation, and implementation of new equipment and processes.
• Provide technical expertise to system users / owners and internal clients for validated equipment, systems, or processes.
• Coordinate validation activities with other departments (QA, Manufacturing, QC, Maintenance, Engineering, etc.).
• Write or update Standard Operating Procedures (SOPs) and validation reports.
• Support audits, inspections, and quality investigations, as needed.
• Train staff in validation study protocol, as required

You are the right person for this role because you have :

A bachelor’s degree in engineering, biotechnology, chemistry, or microbiology (or equivalent combination of education and experience);

Over 5 years of experience in validation within a pharmaceutical manufacturing or quality assurance environment;

Excellent verbal and written communication skills in both English and French;

Strong technical writing and document control skills;

Proficiency in Microsoft Office (Word, Excel, Outlook);

Exceptional attention to detail and proven analytical thinking;

Strong planning, prioritization, and organizational skills;

A critical, quality-focused mindset and strong problem-solving abilities;

A collaborative attitude and excellent interpersonal skills.

Kedrion Biopharma offers you :

A fantastic team who strives at doing things in the best possible way;

A casual environment

A « start-up » culture that values autonomy, innovation and collaboration;

A competitive salary and benefit package;

A unique opportunity to change lives through your commitment and contribution

Note :

Knowledge of French is required for positions permanently located in Quebec so incumbents can communicate with their colleagues and suppliers in Quebec as necessary.

Another language is required for this position in order to communicate with partners and colleagues, who are predominantly located outside Quebec and to understand the technical and scientific documentation used in our industry.

Send us your resume right away !

The usual fine lines :

Kedrion is an equal opportunity employer

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