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Equipment Engineer
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Equipment Engineer
1 month ago
Title: Technical Writer
Location: Equipment Engineer
Job type: 12+ months Contract
PURPOSE AND SCOPE OF POSITION:
The Equipment Engineer supports the successful operation of laboratory and clinical manufacturing operations at their home sites through interaction with internal team members and internal customers, and external service providers. The incumbent conducts tasks assigned by the management independently or with minimum supervision. The Equipment Engineer is responsible for initiating and owning deviations, CAPAs, and change controls, and authoring calibration and maintenance SOPs as well as performing calibrations, maintenance, and qualifications/validations.
REQUIRED COMPETENCIES:
Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.
Knowledge of calibration management and environmental monitoring systems.
Strong critical thinking skills and the ability to work independently.
Excellent interpersonal and communication skills with experience dealing with a diverse workforce where individual initiative, accountability to the team, and professional maturity are required.
Strong multi‐tasking and organizational ability. Ability to effectively manage multiple tasks and activities simultaneously.
Proficiency in Microsoft Office Suite – Word, Excel, PowerPoint, and Outlook; innate ability to learn new software, such as corporate intranet and enterprise applications.
Working knowledge of scheduling software and systems, and inventory management systems, Blue Mountain RAM and Maximo preferred.
Ability to interact effectively with QC, Manufacturing, QA, and Facilities groups.