Job Description

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:

• Create and edit Standard Operating Procedures, Work Instructions, and training materials
• Liaise with Change management in the creation and execution of Change Controls
• Monitor and execute 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 cross-functional 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 on findings
• Develop data visualization tools to improve department communications of Facilities data
• Support existing dashboards and reporting, such as KPI initiatives
• Create metrics to support existing and new processes
• Collaborate with subject matter experts within the Facilities department and across the company
• Keep team members informed of the status of their assigned tasks
• Communicate progress, in the form of metrics and project summaries
• Provide coordination support during regulatory inspections and partner audits, in addition to presenting topics and responding to requests
• Participate in ongoing inspection readiness activities
• Integrate/Migrate data sets into CMMS database

This role might be for you if:

• 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 CMMS systems preferred
• Project Management Experience

Minimum Requirements:

• Requires a bachelor’s or master’s degree in Scientific (Biotechnology) or Engineering (Mechanical, Chemical or Biochemical Engineering) degree. 2-10 years of experience in the biotech-pharmaceutical
• 5+ years of Technical Writing experience
• Experience in the Biotechnology or Pharmaceutical industry

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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