Technical Writer III - Technical Operations

Job Title

Prepare and revise master batch records (MBRs) for manufacturing and packaging and provides input, support and assistance to the Technical Operations, Pharmaceutics & Process Technology (PPT) and Operations groups. Work with Engineering groups to maintain MBR templates and participates in improvement efforts to better improve processes within the Technical Writing department.

Essential Functions

• Work closely with the Technical Operations, PPT Engineers and commercial departments in the generation and approval of work orders.
• Generate and develop all master batch records used in Good Manufacturing Practices environment.
• Maintain and upgrade the MBR templates to conform to current practices
• Work closely with Engineers, Business and Project Managers to understand requirements for each MBR.
• Attend key project team meetings, client teleconferences and on-site visits. May be required to participate in improvement events on behalf of the Technical writing department.
• Perform investigations relating to deficiencies within the department
• Assign change controls and technical packages to the Technical Writers
• Maintain internal logs and metrics.
• Create change controls (as required)
• May be required to assist with report generation from Systems, Applications and Products (SAP).
• Maintain a safe working environment and reports potential hazards.
• Perform alternating or rotating shift work (as required).

Required Qualifications

Education: College Diploma in Science/Technical related field.

Experience: Minimum 4 years related experience.

Equivalency: Equivalent combinations of education, training, and relevant work experience may be considered.

Knowledge, Skills and Abilities: Strong written and oral communication skills. Must be well organized and detail oriented. Ability to lead improvement projects. Knowledge of Good Manufacturing Practices and ability to follow Standard Operating Procedures (SOPs). Ability to work under pressure and meet tight deadlines. Proficiency with Microsoft Office applications. Proficiency with the English Language.

Standards and Expectations

Follow all Environmental Health & Safety Policies and Procedures. Work harmoniously with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives. Carry out all duties within strict compliance to Patheon quality systems SOP's and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Actively engage in and adhere to departmental systems in order to maintain a smooth and efficient workflow (visual management, scheduling systems, shared assets). Be client and patient conscious at all times. Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engage in problem solving. Models positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working. Proactively identifies areas for improvement in the execution of department procedures. Communicate risks to timelines of deliverables in a proactive manner. Consistently strives to improve skills and knowledge in pharmaceutical development (an asset).

Physical Requirements

Light physical effort and fatigue. Walks, sits or stands for limited periods. May require occasional equipment operation including keyboard equipment. Lifts light items for limited duration. Typically located in a comfortable indoor area. There may be exposure to mild physical discomfort from factors such as dust, fumes or odours, temperature extremes, loud noise, strong drafts, or bright lights. Use of Personal Protective equipment may be required and may include any of the following: safety glasses, safety shoes, lab coat, gloves, hair net, beard cover, safety apron, respirator occasionally.

Disclaimer

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as a comprehensive statement of work, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully align with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

Compensation: The salary range estimated for this position based in Ontario is $62,000.00–$85,000.00.