Manufacturing Execution Systems (MES) Special

Job Description

Job Description

EQUAL OPPORTUNITY EMPLOYER

Corden Pharma provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. Corden Pharma embraces fair hiring practices.

CordenPharma is a leading full-service contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs), excipients, and pharmaceuticals Drug Products (DP) and packaging capabilities with >

2,600 employees across the world. Our services enable pharmaceutical and biotech companies to manufacture medicines with the ultimate goal of improving people’s lives.

Our network in Europe and the U.S. offers flexible and specialized solutions across five technology platforms : Peptides, Lipids, & Carbohydrates; Injectables; Highly Potent & Oncology; and Small Molecules. We strive for excellence in supporting this network and are committed to providing the highest quality products for the well-being of patients.

SUMMARY

An MES Technician is responsible for assisting with the implementation of the Manufacturing Execution System with core business systems. An MES Technician, assists with the design and review of digital procedures as they pertain to the pharmaceutical manufacturing environment. An MES Technician plays a crucial role in the continuous improvement of production batch operations through the conveyance of paper-based procedures to the digital platform of the MES.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Assisting with the programming and generation of Electronic Batch Records (EBRs) as they pertain to unit operations in a manufacturing environment, in accordance with current and Good Manufacturing Practices (cGMP)
• Assisting with the programming and generation of Electronic Logbooks (e-Logbooks) as they pertain to plant specific equipment in relation to equipment cleaning and maintenance
• Assisting with the programming and generation of Digital Procedures as they pertain to current paper-based procedures and SOPs
• Ensuring all digitally generated EBRs and procedures are reviewed and approved through an approval workflow as established within the MES platform
• Assisting with the generation of SOPs, URS, FDS, and change control procedures, as required
• Assisting with troubleshooting of MES and Digital Control Systems as needed. This includes participating in an on-call group that is scheduled weekly to ensure the continued functionality of the MES Platform, in reference to 24-hour batch process manufacturing
• Ensuring that reported system functional problems or discrepancies are communicated to management and addressed via an escalation process
• Assisting with vendor inquiries, mandatory system updates, and contracted support agents

LEADERSHIP & BUDGET RESPONSIBILITIES

None.

SAFETY & ENVIRONMENTAL RESPONSIBILITIES

Every individual is personally responsible for the safety and environmental aspects of his or her activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all their knowledge, training, ability, and experience.

QUALITY RESPONSIBILITIES

Corden Pharma Colorado (CPC) is a manufacturer of a variety of pharmaceutical products. In following Current Good Manufacturing Practices (cGMP), Corden Pharma Colorado manufactures in accordance with the US Food and Drug Administration (FDA), International Council for Harmonisation Q7 (ICH), and other global regulations as applicable. This is critical as it is our mission to not place patients at risk due to inadequate safety, quality, or efficacy. CPC’s Quality Management System, which incorporates cGMP, is designed to deliver this quality objective. Attainment is produced through the requisite participation and commitment of all staff across departments and at all levels within the company.

cGMP is the part of Quality Management System ensuring products are consistently produced to accurate quality standards. Adherence to clearly defined procedures, in compliance with the principles of cGMP, is required when performing operations across Corden Pharma Colorado.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and / or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and / or EXPERIENCE

A two-year Associate Degree. Experience of 2 years in a pharmaceutical, refinery, or biological manufacturing environment; or equivalent combination of education and experience.

LANGUAGE SKILLS

Ability to read and interpret technical documents such as safety rules, operating and maintenance instructions, SOPs, User Requirements, Functional Design Specifications, procedure manuals, and batch manufacturing procedures. The candidate must possess the ability to write routine correspondence and present a positive attitude when interacting in group settings with various departments within the organization; and exhibit the ability to contribute to meetings and work effectively with vendors and contractors.

MATHEMATICAL SKILLS

Ability to add, subtract, multiply, divide, and round accurately in all units of measure, using whole numbers, common fractions, and decimals. Ability to understand the metric system.

REASONING ABILITY

Ability to comprehend instructions furnished in written procedures and 3rd party information systems to ensure they are in accordance with site standards and practices.

CERTIFICATES, LICENSES, REGISTRATIONS

Certifications in MES related functions would be preferred, but not required.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is occasionally exposed to wet and / or humid conditions; high, precarious places; fumes or airborne particles; low levels of toxic or caustic chemicals; outside weather conditions; uncomfortable extremes of temperature; and vibration. The noise level in the work environment is usually moderate.

CORE COMPETENCIES

These are the specific areas of knowledge, skill and ability that are important for successful job performance. They must be job related and consistent with business necessity.

SALARY

Actual pay will be based on your skills and experience.

BENEFITS

This post will expire on 2 / 12 / 2025