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Contract Engineering Associate

Lupin Pharmaceuticals Inc.

This is a Full-time position in Somerset, NJ posted November 21, 2021.

Overview:
Lupin is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions.

Together these entities make up the generic and branded U.S.

business.

Lupin has a significant generic pipeline, and a branded focus on women’s health.

Our first Research and Development facility in the US is located in Coral Springs, Florida which focuses on generic and branded orally inhaled and nasal drug products.

Somerset, New Jersey is home to one of twelve commercial manufacturing sites globally and the only commercial manufacturing facility in the United States for Lupin, as well as additional Research and Development teams.

Lupin is prided on being people-focused and centered around how impactful we are with our customers.

Dollars are not a measure of success but rather the people we help along the way.

Responsibilities:

The Contract Engineering Associate will support Engineering Department in revising PM checklists and Calibration program for Manufacturing and Packaging equipments.

Support to update draft SOP to include these changes.
Schedule vendor for calibration as required
Check calibration frequency for instruments associated with manufacturing equipments.
Escort vendor to location, after calibration done review calibration data
Revise frequency after review.
Support to implementation of SOP as required.

Review and approve certificates.

Arrange certificates.

Close work orders in SAP.

Work with IT team for input data in SAP
Any other support for FDA remediation activities related to manufacturing and packaging equipment.
If any data found OOS, evaluate impact and raise deviation under supervisor of reporting manager.
Qualifications:
Qualifications:
Bachelors or Masters in Engineering Degree in Mechanical or Electrical Engineering or related discipline preferred
1+ years Expereince Required or similar field
Above average computer and technical skills, SAP experience a plus
Intermediate skills for Microsoft office i.e (Word, Excel and PowerPoint)C
Reasonable communication skills.