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Equipment Validation Engineer

4 months ago

Stafford Twp, United States Artech Full time

Equipment Validation Engineer

Warren, NJ

100% Onsite Required

Required Skills:

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.

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 Client 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.

Job Description:

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. This individual will conduct 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.

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).

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 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 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.

Supports multiple sites within Warren and Summit.

This 6+ Month Assignment Starts ASAP

Must Be Able To Work As An Hourly W2 Employee

ALPHA S REQUIREMENTS (phone number removed)