Technical Writer III - Lab Operations

Job summary

The role involves preparing analytical method validation protocols, reports, and specifications to ensure compliance with regulatory and industry standards. Additionally, the position requires providing technical training to other writers and performing analytical assessments of compendial updates.

Job details

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. DESCRIPTION: Join a leading scientific organization making meaningful contributions to global health, environmental protection, and food safety. As a Technical Writer III/Validation Specialist, you'll create clear, concise documentation that enables our customers and internal teams to effectively utilize our products and processes. Working across multiple departments and technologies, you'll translate complex scientific and technical information into user-friendly content that supports our mission of enabling customers to make the world healthier, cleaner and safer. Summary: Prepares analytical method validation protocols and reports, method transfer protocols and reports, analytical methods, and specifications used by the Development Laboratory ensuring they meet current regulatory, corporate and industry standards. In addition to document preparation, provides training to other Scientific Technical Writers. Essential Functions: Prepares technical documents such as method validation and transfer protocols, reports, analytical methods, and specifications Performs analytical assessments of compendial updates to identify required laboratory activities Generates method transfer plans for incoming projects Attends client meetings related to technical document requirements. Capable of writing more advanced reports such as Elemental Impurity Risk Assessments. Provides training and technical expertise to other Scientific Writers. May be essential to perform alternating or rotating shift work (as required) REQUIRED QUALIFICATIONS Education: Bachelor of Science (B.Sc.) in Chemistry or related science. Experience: Minimum 5 years’ previous pharmaceutical laboratory work experience and strong knowledge of analytical method validation requirements. Experience in laboratory testing and method validation Experience in preparation of technical Documents Equivalency: Equivalent combinations of education, training, and relevant work experience may be considered. Knowledge, Skills and Abilities: Excellent Good Manufacturing Practices, Good Laboratory Practices (GLP), International Conference on Harmonization (ICH) and United States Food and Drug Administration (FDA) compliance knowledge. Knowledge of regulatory requirements including USP/NF and Ph. Eur. Proficient in Microsoft Office Suite (Word, Excel, and PowerPoint, Chemstation and OpenLab. Well organized and detail oriented. Excellent interpersonal and communication skills (both oral and written). Ability to work well independently and in a team environment with limited supervision. Ability to prioritize multiple tasks. Proficient with the English language. Compensation The estimated annualized pay range for this position in Ontario is $62,500.00–$90,000.00.

What you’ll do

The role involves preparing analytical method validation protocols, reports, and specifications to ensure compliance with regulatory and industry standards. Additionally, the position requires providing technical training to other writers and performing analytical assessments of compendial updates.

Requirements

Candidates must hold a Bachelor of Science in Chemistry or a related field and possess at least 5 years of pharmaceutical laboratory experience. Strong knowledge of GMP, GLP, ICH, and FDA regulatory requirements is essential for this position.

Listed skills

• Training · Preferred
• Quality assurance · Preferred
• Data analysis · Preferred
• Microsoft Office Suite · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Technical writing
• Analytical method validation
• GMP
• GLP
• ICH compliance
• FDA compliance
• Regulatory documentation
• Method transfer
• Elemental impurity risk assessment
• Microsoft Office Suite
• Chemstation
• OpenLab
• Scientific documentation
• Training
• Data analysis
• Quality assurance
• Good Laboratory Practice (GLP)
• Method Validation
• Industry Standards
• Validation Protocols
• Analytical Method
• Shift Work
• Microsoft Excel
• Drug Administration
• Chemistry
• Good Manufacturing Practices
• Communication
• Document Preparations
• English Language
• Food Safety And Sanitation
• Laboratory Testing
• Microsoft Office
• Openlab
• Pharmaceuticals
• Microsoft PowerPoint
• Safety Standards
• Risk Analysis
• Prioritization
• Detail Oriented

Job areas

• Science & Research
• Manufacturing
• Healthcare
• Laboratory Operations Technician
• Technical Writer
• Authors and Related Writers
• Technical Writers