TekWissen group is a workforce management provider throughout the USA and many other countries in the world. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps their customers to deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, Bioscience, Biopharmaceuticals, Custom manufacturing, Biotechnology, Life science ingredients, Nutrition, Microbial Control, Agriculture, Materials Science, Personal Care, and cell and gene therapy.
General Deliverables / Responsibilities:
Manufacturing Support
Develop technical knowledge on manufacturing equipment and processes
Support resolution of major equipment breakdowns and quality issues in the suites
Provide SME support to Manufacturing and other departments for the design and operation of process equipment.
Conduct troubleshooting and technical analyses on manufacturing equipment and processes including PI data analyses, CIP/SIP circuit review, MOC analyses, flow path analyses, etc.
Projects
Planning and execution of plant projects involving equipment changes and process improvements.
Execute commissioning protocols (installation, operation, CIP/SIP, wet testing) with support and guidance from supervisor
Documentation
Review/revise Engineering and Manufacturing related SOP's, work instructions, and maintenance assessments/procedures as a result of CAPA, equipment/process changes, error prevention activities, etc.
Complete engineering review/approval of batch records
Initiate EDCRs for updates to Engineering documents including engineering drawings