Production Systems Specialist: cGMP & Data Backup

RXinsider LTD.; Cherry Hill Township, Northern (NJ, KY); Hybrid; USD 60,000 - 120,000; Full time

Benefits offered by this job

Annual bonus

401(k) program

PTO 20 days

Personal days

Company holidays

Benefits package

Job summary

Hikma Pharmaceuticals USA Inc. in Cherry Hill is seeking a Specialist, Production Systems to support Commercial Production.

You will administer user accounts for production systems, manage software archives for backup and disaster recovery, and work with IT to ensure secure data capture and business continuity. The role requires 3–5 years with production systems, knowledge of cGMP, and the ability to work varying shifts.

Qualifications

• Bachelor’s degree in Sciences, Engineering or a related technical field OR Associate degree in a technical discipline with up to 5 years relevant pharmaceutical production systems experience may be considered.
• Ability to communicate effectively at all levels in verbal and written form, including technical/business writing.
• Proficient in Microsoft Word, Excel, Access, computer software.
• Direct industry knowledge of Production Computerized systems preferred (Systech, Optel, Vision Systems, e.g)
• Ability to work independently or in teams.
• Ability to walk some distance 1 to 3 miles, stand for 3 to 6 hours and lift 10 to 40 lbs during the course of a work day as required.
• Ability to work any shift (1st, 2nd or 3rd) on any day of the week (7 days) as duties require.

Responsibilities

• Responsible for Stand alone User Administration of Computer Controlled Systems in the Cherry Hill Production environment to ensure compliance to 21 CFR Part 11 and cGMP practices.
• Responsible for Software Archival as determined by Site management and cGMP practices. Archival of Software Backup of Production based system for Disaster Recovery, and Periodic Data backup, etc.
• Works with Information Technology to automate backup systems for secure, timely data capture and continued business continuity.
• Maintain database for Software Records and User maintenance
• Handles routine tasks timely, accurately.

Education

Bachelor’s degree in Sciences, Engineering or a related technical field

Associate degree in a technical discipline

Tools

SYSTEC

OPTEL

VISION

Job description

Hikma Pharmaceuticals USA Inc. in Cherry Hill is seeking a Specialist, Production Systems to support Commercial Production.

You will administer user accounts for production systems, manage software archives for backup and disaster recovery, and work with IT to ensure secure data capture and business continuity. The role requires 3–5 years with production systems, knowledge of cGMP, and the ability to work varying shifts.