Specialist, Production Systems

Job Title: Specialist, Production Systems

Location: Cherry Hill

Job Type: Full-time

Req : [12518]

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 800 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe.

Through our 32 manufacturing plants, eight R&D centers, and 9,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Specialist, Production Systems to join our team. In this role, you will be responsible for supporting Commercial Production at the Cherry Hill pharmaceutical manufacturing facility through the Administration of User Account Creation and Maintenance. You will leverage Software Archival to support (Backup, Restoration, Disaster Recovery), System Administration and Troubleshooting for Production based systems.

You will also assist in investigations of manufacturing challenges, data integrity issues to support Commercial production equipment usage and product release

• 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.

• Internal:
  Daily/Weekly communication with immediate supervisor. Scheduling with Production Planning, Line Leaders for Routine Backup/Equipment Backups and User account administration. Interaction with IT for networked solutions.
• External: FAT/Vendor interaction for Archive, Backup functionality of new equipment. Offsite training.

We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:

• 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.

• 3-5 years’ experience working with Production equipment
• Knowledge of Data Backup of Production based software systems and data support of production-based systems.
• Proven experience with administration and user account maintenance of cGMP…