Equipment Engineer Pharma (Onsite- Warren, NJ)

Stage 4 Solutions • Warren, NJ

270d

About The Position

We are seeking an Equipment Engineer for a global pharmaceutical company. The focus of the role is to support 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. 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. This is a 40-hour per-week, 12-month contract (extensions possible), 100% onsite role in Warren, NJ. This is a W2 role as a Stage 4 Solutions employee. Health benefits and 401K are offered.

Requirements

• 3+ years of experience in FDA-regulated industry
• 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, 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.
• 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, e.g., Blue Mountain RAM and/or Maximo Computerized Maintenance Management System (CMMS) preferred.
• BS in Engineering or Science related discipline preferred.

Responsibilities

• Executes equipment calibration, preventative maintenance, performance verification, troubleshooting and repair activities in laboratory and manufacturing areas, as required per current scheduling (CMMS) System.
• Escorts and supervises vendors for calibration, preventative maintenance, performance verification and repair functions as required per current scheduling (CMMS) System.
• Reviews and approves vendor executed calibration, maintenance, repair, and performance verification records for accuracy, and completeness.
• 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.
• Documents and populates calibration/maintenance information in WPT (Work Plan Template) or MDT (Measurement Data Template) using CMMS system.
• Executes requalification on Controlled Temperature Units (ex. Refrigerators, Freezers (which includes -20°C / -80°C Freezers), Incubators, Cryotanks, Cryopods, and Storage Rooms/Areas).
• Supports multiple sites within Warren and Summit.
• Supports clinical manufacturing on-call equipment troubleshooting activities during weekends as required.
• Support the development, review and approval of calibration and maintenance plans in site CMMS system.
• 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.

Benefits

• Health benefits
• 401K

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree