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About TSR:

TSR is a relationship-based, customer-focused IT and technical services staffing company.

For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of companies both large and small with well refined candidate screening, timely placement, and a real understanding of the right skill sets required by our clients.

Mission & Vision

We do not believe in building a vision around the company but building a company around our vision, which is simply;

Every employee’s voice matters, their effort is appreciated, and their talent is rewarded.

We challenge each employee daily, to raise the bar on how we treat our consultants and candidates. For far too long in this industry, candidates have been ghosted, lied to, or placed at a client and then forgotten about. Each day our staff works tirelessly at qualifying and placing, top talent with our clients, in a compassionate and caring manner.

Not every candidate is a match for the job, but every candidate and consultant will be treated with respect and professionalism.

Equipment Engineer

Job Description

  • Location: Warren, NJ
  • Type: Contract
  • Job #78542

Our client, a leading pharmaceutical company, is hiring an Equipment Engineer on a contract basis.

Work Location:
Warren, NJ – 100% on site

Summary:
The LSM (Lab Systems Management) 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.

Knowledge/Skills Required/Education:

  • BS in Engineering or Science related discipline required.
  • 2 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 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 multitasking 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.

Responsibilities:

  • 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 -20C / -80C 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 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 NCRs investigations.
  • Review and approve calibration and maintenance work.
  • 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.

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.
  • Working safely and effectively when working alone or working with others will be required.
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