Our client, a world renowned biotechnology company, is looking for a Validation Engineer to join their team.
Responsible for generating, executing, and finalizing equipment, IQ,OQ,SIP and cleaning validation. Expected to be knowledgeable of and work within GMP regulations. Requires protocol generation, execution, data analysis, troubleshooting skills, deviation investigation and protocol report closure for the site. Working closely with Engineering, MSAT, Quality Assurance and Manufacturing. requires strong communication and collaboration skills, the ability to work within teams, facilitate meetings and lead teams. Review validation lifecycle documents for compliance with CFRs, corporate policies (QP/QS documents), and site procedures (SOP's). Generation of Tracability Matrix Participate in cross-functional team meetings and where required Sound knowledge and understanding of GMP guidelines, USP, and CFRs applicable to the pharmaceutical/biotechnology industry.
Ability to manage technical projects through to completion to achieve results. Logically and methodically works through complex problems to identify root causes and provide rational solutions. -Proven effective verbal and written communication skills. Delivers results Understands the validation process and recognizes supplier limitations and customer expectations. Accountable for projects, and communication. Seeks guidance and support when required.
Education: Bachelor's Degree Required