Equipment Engineer jobs in Somerset, NJ

• 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 consultant 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.

• 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 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.

• 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.
• 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.
• Ability to interact effectively with QC, Manufacturing, QA, and Facilities groups.
• BS in Engineering or Science related discipline.
• Minimum 2 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.).

• Working knowledge of scheduling software and systems, and inventory management systems, Blue Mountain RAM and Maximo.
• Maintenance coordination / planning experience.
• Experience working in a clinical environment.

• 401k Retirement Savings Plan administered by Merrill Lynch
• Commuter Check Pretax Commuter Benefits
• Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro

Larah.Robledo@eclaro.com

About the Company:
Eclaro

Eclaro is a Business and Technology Consulting Firm that connects top talent with opportunities nationwide. We have direct access to Hiring Managers from leading Fortune 1000 organizations in almost every industry segment, with particular expertise in:

• Technology and Business Consulting
• Financial Services and Insurance
• Pharmaceuticals and Life Sciences
• Consumer Products, Public Sector, and Utilities

Eclaro provides fully customizable, comprehensive talent acquisition and management of seasoned professionals through a number of business models, including:

• Consulting
• Professional Hiring
• Global Integrated Delivery™
• Managed Services

Eclaro recruits and manages a staff of highly skilled individuals in an array of specialized disciplines enabling our clients to leverage new opportunities, respond to increased and changing demands, and increase their profitability.

Eclaro’s Management Team averages over 25 years of experience in partnering with clients in technical, corporate operations and human capital solutions. We hold ISO 9001:2008 certification and have achieved SOC 2 Type 2 certification in Security, Availability and Confidentiality. Eclaro’s decades of expertise and collaborative practice have proven that The Right People are The Answer.

Company Size:
500 to 999 employees

Industry:
Staffing/Employment Agencies

Founded:
1999

Website:
http://www.eclaroit.com