Manufacturing Systems Specialist

Hikma; Cherry Hill Township (NJ); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Annual bonus

401(k)

PTO 20 days

Personal days

Holidays

Health benefits

Tuition reimbursement

Parental leave

Job summary

Hikma Pharmaceuticals USA Inc. seeks a Specialist, Production Systems in Cherry Hill. You will administer stand-alone and networked production systems, ensure 21 CFR Part 11 compliance, and support backup, restoration, and disaster recovery efforts.

You will collaborate with IT and production teams to protect data integrity and continuity, maintaining software records and user accounts across critical systems.

Qualifications

• Weakness in communication is avoided; ability to write clearly and document processes.
• Proficiency with Microsoft Word, Excel, and Access is preferred.
• Experience with production computerized systems and cGMP practices.

Responsibilities

• Administer user accounts for production systems and ensure compliance with 21 CFR Part 11.
• Support software archival, backup, restoration, and disaster recovery planning.
• Collaborate with IT to automate secure backups and maintain data integrity.
• Maintain records for software, users, and system configurations.

Skills

Communication

Microsoft Office

cGMP knowledge

Tools

SYSTEC

OPTEL

VISION

Data backup systems

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
• Clear communication skills, cGMP documentation

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)
• 11 company paid holidays
• Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
• Employee discount program
• Wellbeing rewards program
• Safety and Quality is a top organizational priority
• Career advancement and growth opportunities
• Tuition reimbursement
• 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.