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Biopharmaceutical Technical Writer
2 months ago
This role is for Canadian Citizens who would like to work onsite in Upstate New York.
About the RoleAs a Biopharmaceutical Technical Writer, you will work with a group of engineers involved in the design, automation, commissioning, and start-up of various processes, systems, and facilities.
Key Responsibilities- Creating and editing Standard Operating Procedures and Work Instructions
- Liaising with Change management in the creation and execution of Change Controls
- Monitoring and executing Corrective and Preventative Actions (CAPAs)
- Working closely with the Facilities team to develop and expand the data and analytics program within the Facilities department
- Communicating with multiple teams to understand their analytical needs
- Developing tools to assist with collecting, storage, retrieval, preparation, analysis, and distribution of data
- Performing rigorous analyses on large, complex data sets and providing strategic insights, hypotheses, and conclusions based upon findings
- Developing data visualization tools to improve department communications of Facilities data
- Supporting existing dashboards and reporting, such as KPI initiatives
- Creation of metrics to support existing and new processes
- Collaborating with subject matter experts within the Facilities department and across the company
- Keeping team members informed of the status of assigned work
- Communicating progress in the form of metrics and project summaries
- Providing coordination support during regulatory inspections and partner audits, in addition to presenting topics and responding to requests
- Participating in ongoing inspection readiness activities
- Integration/Migration of data sets into CMMS database
- Experience with Quality Systems
- Strong analytical skills with attention to detail
- Excellent written, verbal, and interpersonal communication skills
- Ability to work independently within a tight deadline environment
- Handle multiple projects simultaneously
- Experience with data visualization software (Qlik, Tableau, Spotfire, etc.) preferred
- Experience with SQL preferred
- Experience with a statistical computing language such as R preferred
- Experience with SharePoint Lists and Workflows preferred
- Six Sigma Black Belt, or Operational excellence certification preferred
- Experience with CMMS system preferred
We are committed to cultivating an authentic and diverse organization, welcoming all those interested in our work to apply.
We are committed to providing an accessible and inclusive interview experience. Please inform us of any accommodations needed to assist you during the interview process.
Applications will be accepted until the role is filled. Only those applicants who are selected for an interview will be contacted. No phone calls please.
