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Equipment Engineer - Warren, United States - Aequor
Description
Position: Equipment Engineer
Location:Warren NJ 07059
Duration: 12 months (possibility of extension for the right candidate depending on performance)
Pay rate: $61.08/ hour on W2
100% onsite
EDUCATION AND EXPERIENCE
BS in Engineering or Science related discipline required
Minimum 3 years of experience in an 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 is 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:
The environment may include working in an 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.
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 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:
Knowledge of cGMP, GXP, GAMP, and 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.
DUTIES AND RESPONSIBILITIES
Operational Activities
Executes equipment calibration, preventative maintenance, performance verification, and repair activities in laboratory and manufacturing areas.
Supervises vendors for calibration, preventative maintenance, performance verification, and repair functions.
Reviews and approves vendor-executed calibration, maintenance, repair, and performance verification records for accuracy, and completeness.
Ensures all calibration, PM, and performance verification records are filed appropriately after approval.
Executes requalification on Controlled Temperature Units (ex. Refrigerators, Freezers (which include -20°C / -80°C Freezers), Incubators, Cryotanks, and Cryopods).
Supports multiple sites within Warren and Summit.
Owns and supports deviations and investigations that result from calibration or performance verification activities, along with developing and supporting the implementation of corrective and preventive actions.
Authors and supports the development, revision, and review of written procedures for calibration, preventive maintenance, and performance verification of equipment.
Support the development, review, and approval of calibration and maintenance plans in the site CMMS system.
Supports the execution of process improvement studies, as required.
Adheres to written policies and procedures governing the LSM department activities and the equipment they manage to ensure compliance with approved standards.
Maintains a positive relationship with the site customers and outside vendors while promoting a positive team environment.
Follows cGMP (current Good Manufacturing Practices) and ALCOA principles ('ALCOA' defines that data should be Attributable, Legible, Contemporaneous, Original, and Accurate) In addition, 'ALCOA+' guidance recommends that data is also Complete, Consistent, Enduring, and Available.
Inventory Management
Work with the Planning group to ensure the system is updated as calibration, maintenance, and performance verification activities are performed.
Approves Change Request, Asset Inductions, and Work Requests.
Approving Calibration and Maintenance forms.
Perform NCR's investigations.
Review and approve calibration and maintenance work.
Regulatory Responsibilities
Maintains all required Corporate, Facilities, and EHS training as required.
Adheres to all safety procedures and hazard communication.
May be called upon to act as SME in both internal and regulatory audits.
