Manufacturing Systems Specialist

Hikma Pharmaceuticals; Cherry Hill Township (NJ); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Annual bonus

401(k) matching

PTO 20 days

Personal days (3)

Health, dental, vision benefits

Employee discount

Career growth opportunities

Parental leave

Job summary

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

You will administer user accounts for computer controlled systems, manage software archival for backup and disaster recovery, and work with IT to ensure data integrity and continuous operations. Responsibilities include maintaining records, coordinating backups, and supporting investigations of manufacturing challenges.

Qualifications

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

Responsibilities

• Stand alone User Administration of Computer Controlled Systems in the Cherry Hill Production environment to ensure compliance to 21 CFR Part 11 and cGMP.
• Software Archival for Disaster Recovery and periodic data backup.
• Collaborate with IT to automate backup systems and ensure business continuity.
• Maintain database for Software Records and User maintenance.
• Handle routine tasks timely and accurately.

Skills

Data backup

System administration

cGMP knowledge

User maintenance

Tools

SYSTEC

OPTEL

VISION Programs

Job description

Job Title: Specialist, Production Systems

Location: Cherry Hill

Job Type: Full-time

About Us:

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.

Description:

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

Key Responsibilities:

Duties:

• 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.

Communications & Working Relationships:

• 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.

Qualifications:

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:

• Minimum: 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.

Experience:

• 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 systems.

Skills:

• Knowledge of software systems such as SYSTEC, OPTEL, VISION Programs, Data Backup local and network solutions

What We Offer*:

• Annual performance bonus, commission, and share potential
• Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 4% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
• A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
• 3 personal days (prorated based on hire date)
• Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
• Employee discount program
• Safety and Quality is a top organizational priority
• Career advancement and growth opportunities
• Paid maternity and parental leave

*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.

Equal Opportunity Employer:

Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.