Biopharmaceutical Technical Writer

On-Site Biopharmaceutical Technical Writer - Upstate New York

ADVENT's services include process engineering, automation engineering, project engineering, HVAC/facility system design, process development, start-up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.

The successful candidate will work with a group of engineers involved in the design, automation, commissioning and start-up of various processes, systems, and facilities. This is an outstanding opportunity to join our growing team!

Essential Duties and Responsibilities may include, but are not limited to, the following:

• Creating and editing Standard Operating Procedures and Work Instructions
• Liaise with Change management in the creation and execution of Change Controls
• Monitor and Execute of Corrective and Preventative Actions (CAPAs)
• Work closely with the Facilities team to develop and expand the data and analytics program within the Facilities department.
• Communicate with multiple teams to understand their analytical needs. Develop tools to assist with collecting, storage, retrieval, preparation, analysis, and distribution of data.
• Perform rigorous analyses on large, complex data sets and provide strategic insights, hypotheses, and conclusions based upon findings.
• Develop data visualization tools to improve department communications of Facilities data.
• Support existing dashboards and reporting, such as KPI initiatives.
• Creation of metrics to support existing and new processes.
• Collaborates with subject matter experts within the Facilities department and across the company.
• Keeps team members informed of the status of assigned work.
• Communicates progress in the form of metrics and project summaries.
• Provides coordination support during regulatory inspections and partner audits, in addition to presenting topics and responding to requests.
• Participates in ongoing inspection readiness activities.
• Integration/Migration of data sets into CMMS database

This role might be for you if:

• Experience with Quality Systems
• Strong analytical skills with attention to detail.
• Requires 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.
• Project Management Experience

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.