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Equipment Engineer - Trenton, United States - Primary Talent Partners, Inc.
Description
3 days agoBe among the first 25 applicants
Primary Talent Partners has an opening as an Equipment Engineer with one of our global Pharmaceutical clients. This is an initial 12-month contract to start.
100% onsite
Contract: 12- month to start
Target Pay:
$57-61/hour
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 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 CompetenciesKnowledge 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.
Proficiency in Microsoft Office Suite – Word, Excel, PowerPoint, and Outlook; innate ability to learn new software, such as corporate intranet and enterprise applications.
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 includes -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.
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.
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.
Work with Planning group to ensure system is updated as calibration, maintenance and performance verification activities are performed.
Approves Change Request, Asset Inductions, and Work Request.
Approving Calibration and Maintenance forms.
Perform Client'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.
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.
Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.
If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at (url removed)#PTPJobs
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