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Sr. Validation Engineer, Equipment
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Mechanical Design/Equipment Design Engineer
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Equipment Engineer - Trenton, United States - Sunrise Systems
Description
100% onsitePURPOSE AND SCOPE OF POSITION:
The LSM 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 LSM 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.
EDUCATION AND EXPERIENCE
BS in Engineering or Science related discipline required
Minimum 3 years of experience in FDA-regulated industry.
Minimum 3 years of experience working directly with laboratory equipment (ex. centrifuges, temperature/humidity meters, balances, freezers, refrigerators etc.)
Maintenance coordination / planning experience preferred.
Experience working in a clinical environment preferred.
WORKING CONDITIONS:
Physical / Mental Demands:
Occasional stooping, bending, stretching, pushing, pulling, reaching, and/or lifting up to 25 lbs.
Ability to sit, stand, walk, and move within workspace for extended periods.
Ability to perform repetitive tasks, including hand to finger manipulations, grasping, pushing, and pulling.
Environmental Conditions:
Environment may include working in office, laboratory, or manufacturing area.
Donning proper gowning and/or PPE such as safety glasses and shoes in an environment with hazardous materials and waste will be required.
Working safely and effectively when working alone or working with others will be required.#J-18808-Ljbffr
