Technical Writer

1 week ago

Windsor, Canada BioVectra Full time

The candidate will be responsible for:

Writing and managing the change control of technical documents that directly support manufacturing and special projects. Working with the project team in identifying specifications and requirements for materials/equipment destined for use in the manufacture of APIs. Ensuring documentation is in place for management of receipt, traceability and compliance under cGMP guidelines. Consulting and communicating with suppliers and external sales reps concerning the technical details of the scope of service or deliverable and aligning internal documents accordingly through new document creation or change control. Preparing validation protocols, associated reports, and other documentation required to support the successful execution of projects. Providing training to manufacturing employees and conducting orientation for new employees in standard operating procedures and technical process procedures. Facilitating continuous improvement and best practice development within the Production unit. Preparing spreadsheets to track critical project data, preparing summary reports, and identifying process improvement opportunities using statistical methods. Working with the project team in the identification of instruments, equipment and process aids for the maintenance and manufacturing departments for the Facility and recommending supplier options. Providing administrative support for the facility staff and sourcing, purchasing, negotiating equipment and process aids for API processes. Adhering to BIOVECTRA’s Health and Safety Policy as outline in CP0010 Occupational Health and Safety Policy, Statements of Principle, and Responsibilities. Additional duties assigned, based on business needs and the department manager’s request.

The successful candidate for this position should have:

Postsecondary education in technology, science, or related field. Two (2) years’ experience working in the pharmaceutical industry. Familiarity with Q7A “Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients” and the ability to apply the Q7A guidance to project requirements is desired. One year of technical writing experience considered an asset.

BIOVECTRA offers a competitive salary and benefit package. Interested candidates are asked to apply by choosing the “Apply Now” button.

Closing: July 5, 2024

Individual accommodations due to a disability are available upon request for candidates taking part in all aspects of the selection process. All qualified applicants will receive consideration for employment without regard to age, race, religion, ethnicity, gender, disability, citizenship status, marital status, actual or perceived sexual orientation. BIOVECTRA is committed to creating an inclusive environment and building a team that represents a variety of backgrounds, perspectives, and skills. We value diversity and recognize that experience comes in many forms and skills are transferable. Please view this description as a general overview, but not a mandatory comprehensive list. If you feel passionate about our efforts and believe that you have the skills to contribute and lead in this role, apply We thank all interested parties; however, only those applicants considered for an interview will be contacted.

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