LSM Equipment Engineer at Eclaro

Warren, NJ

About the Job

LSM Equipment Engineer
Job Number: 24-01414

Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a LSM 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:

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.
Conducts tasks assigned by the management independently or with minimum supervision.
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 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:
- 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, 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.

Required Qualifications:

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.)

Preferred Experience:

Maintenance coordination / planning experience
Experience working in a clinical environment

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:
Chris Imbien
Chris.Imbien@eclaro.com
(843) 872-9257

Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.