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Equipment Engineer

1 month ago

Warren, United States LanceSoft Full time
Job Title: Engineering - Equipment Engineer
Location: Warren, NJ 07059
Duration: 12 months

Pay Range - $45-52/hour

Job Description:
100% onsite
Bachelor's degree required.

Purpose and scope of position:
  • 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.
  • The incumbent conducts 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.

Required Competencies:
  • 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 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 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.
  • 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 Laboratory Systems Management 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.

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

Additional Job Requirements: None

Employee Benefits:

At LanceSoft, full time regular employees who work a minimum of 30 hours a week or more are entitled to the following benefits. (To be bought)
  • Four options of Medical Insurance
  • Dental and Vision Insurance
  • 401k Contributions
  • Critical Illness Insurance
  • Voluntary Permanent Life Insurance
  • Accident Insurance
  • Other Employee Perks
About LanceSoft
LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch.
EEO Employer
LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time