Required Skills
equipment validation, cleaning validation, SOW, Documentation, Soltraqs, TrackWise, technical report writing, risk assessment, change control, change plans, change control documents, Quality, Deviations Investigations, Risk Analysis & Assessments, IQ, Installation Qualification. OQ, Operational Qualification, PQ, Performance Qualification
Job Title: Engineer - Degree Optional III
Location: Worcester MA 01605
Duration: 6+ months (Possibilities of extension)
Note from the Manager:
• The Engineering Department is in need of an Engineer with technical writing experience to evaluate and write change control documents to enable aggressive deadlines to be met to support a biologics GMP environment.
• Primarily these documents are related to equipment validation and cleaning validation, but also cover other engineering activities so an Engineering background will be helpful.
• Other writing tasks are related to continuous improvement of our business practices and quality systems to improve effectiveness into the future.
• TrackWise (also known as Soltraqs) experience is a MUST as all of our change plans go through this system.
• Candidates should have at least 2+ years of validation or change control experience in the pharmaceutical industry and 4+ years of procedure, risk assessment and technical report writing experience.
• Additionally, candidates with previous cleaning Validation experience will be a BIG plus, but not a requirement.
*** This Assignment is set to run until the end of the year, but could be extended based on performance and departmental need. ***
To apply:
Call me – 630-315-7397
Email me on kunal.shah@collabera.com