- 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.
- 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.
- 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.
- 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.
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Equipment Engineer - Warren, United States - Sunrise Systems
Description
Job Title: Equipment Engineer
Job ID:
Location: Warren, NJ, 07059
Duration: 12 Months of W2 Contract
100% onsite
PURPOSE 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 incumbent conducts tasks assigned by the management independently or with minimum supervision. 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:
EDUCATION AND EXPERIENCE
WORKING CONDITIONS:
Physical / Mental Demands:
Environmental Conditions:
