Equipment Engineer
Job Number: 25-04096
Job Number: 25-04096
Be part of a company that delivers life-changing healthcare solutions. ECLARO is looking for an Equipment Engineer for our client in Warren, NJ.
ECLARO’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
Position Overview:
- The LSM 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.
Responsibilities:
- Operational Activities:
- 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.
- Documents and populates calibration / maintenance information in WPT (Work Plan Template) or MDT (Measurement Data Template) using CMMS system.
- Modifies or update CMMS documentation as required.
- Prepares reports and keeps records on calibration inspection, testing, and repairs.
- 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 as required.
- Ensures all calibration, PM, and performance verification records are filed appropriately after approval.
- Contacts supplier for quotation on external calibration / PM of the equipment and calibration standards.
- Initiates, participates, and assists in resolution of quality investigations.
- Authors and supports the development, revision, and review of written Standard Operating Procedures (SOP) for calibration, preventive maintenance, and performance verification of instruments / equipment.
- Supports 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.
- Performs inventory of the equipment and / or standards in the labs as required.
- Maintains a positive relationship with the site customers and outside vendors while promoting a positive team environment.
- Participates actively in special projects as required.
- Ensure low cost of the Laboratory Systems Management (LSM) department (Reducing overtime, implementing innovative ideas).
- Plans, justify and implement cost reduction small projects.
- Usage of several test equipment and tools (e.g., pressure gauges, temperature, humidity meters, flow meters, particle counters and temperature mapping equipment etc.).
- 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.
- 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.
- 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.
Required Skills:
- 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.
- 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 Engineering & Facilities groups.
Preferred Qualifications:
- BS in Engineering or Science related discipline.
- 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.
- Experience working in a clinical environment.
- Working knowledge of scheduling software and systems, and inventory management systems, e.g., Blue Mountain RAM and / or Maximo Computerized Maintenance Management System (CMMS).
Pay Rate: $54 - $57 / hour
If hired, you will enjoy the following ECLARO Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through ECLARO
If interested, you may contact:
June Binuya
junethel.binuya@eclaro.com
212-804-7476
June Binuya | LinkedIn
Equal Opportunity Employer: ECLARO values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status, in compliance with all applicable laws.
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