Biopharmaceutical Technical Writer

2 weeks ago

Albany, United States Trinity Consultants - Advent Engineering Full time

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.

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