PD Process Validation Technical Writer

Location
Milford, MA, United States
Posted
Mar 04, 2019
Ref
800497
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Process Validation Technical Writer

Reporting to the Technical Manager, Process Validation, this role will provide support of Process Validation activities for Avecia's manufacturing processes.

Key job responsibilities:
  • Preparation of process validation documentation in accordance with SOPs in support of Process Development deliverables across multiple projects. Documentation includes, but is not limited to, process development/validation risk assessments, protocols and reports.
  • Contribute to the standardization of approaches to process validation across projects.
  • Contribute to activities executed to support process design/characterization, process risk assessments and process monitoring.
  • Coordinate documentation review with the Quality Unit to ensure documents meet established procedures.

Qualifications/skills/experience required:

BSc in Chemistry or related field and 2 years relevant experience
Knowledge of cGMP
Proficiency in MS Word and MS Excel and in the preparation of technical reports in the English language
Excellent communication skills and ability to interact with technical laboratory staff at all levels to discuss the content of technical documentation
Ability to work under minimal supervision with excellent judgement in problem solving and elevating issues when necessary.
Experience with Statistical Analysis software is not required but is beneficial