MS&T Engineer

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

Provides process engineering support for commercial, or near-commercial, manufacturing processes, in assigned group or plant, through developing and implementing continuous improvements in the production of bulk pharmaceutical intermediates and active pharmaceutical ingredients.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Include the following. Other duties may be assigned.

• Establishes and maintains strong, transparent, and effective day-to-day working relationships between Manufacturing, Maintenance & Facilities, R&D, internal support, regulatory groups, and CPC customers related to assigned duties
• Provides day-to-day support to assigned processes; at times requiring attention outside of the normal work hours
• Implements process improvements and optimizations that reduce costs; improve yields, cycle times or product quality; resolves or prevents safety, health, and environmental impacts; reduces down time; improves process consistency; and improves process robustness
• Performs process troubleshooting to resolve operating or product problems; identifies and implements solutions to improve process robustness
• Assists with planning and execution of process changeovers
• Develops and implements detailed plans for capital and expense projects
• Creates and modifies support documents, such as user requirements, equipment specifications, etc.
• Responsible for ensuring that hazardous and non-hazardous wastes streams are identified, characterized, and properly communicated to the Environmental Department
• Supports Manufacturing through writing, changing, and maintaining production-related documentation; which includes batch records, change control, deviations, and investigations. Ensures that documentation is consistent with the process filing
• Supports the growth and retention of knowledge capital via the process technical library by authoring lab, campaign, process investigation, process definition (control strategy), process optimization, and process fit reports
• Process Training - Writes and delivers training via PJT, process briefings, SOPs, guidelines, etc. to Operations staff
• Contributes to meeting Process Safety Management compliance by participating in Process Hazard Analysis reviews, updating mass and energy balances, and other engineering data for the assigned process
• Strives to improve professional skills by participating in On-The-Job Training, attending guest lectures, being an active member of a professional organization, and attending formal training courses and conferences

LEADERSHIP & BUDGET RESPONSIBILITIES

This position is responsible for providing leadership and project management to assigned projects.

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 BS in Chemical / Biochemical Engineering with 3 months experience.

LANGUAGE SKILLS

Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format. Ability to effectively present information to top management, public groups, and / or boards of directors.

MATHEMATICAL SKILLS

Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.

REASONING ABILITY

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form, and deal with several abstract and concrete variables.

CERTIFICATES, LICENSES, REGISTRATIONS

None.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform 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 frequently required to stand, sit, and talk or hear. The employee is occasionally required to walk; work with hands; reach above shoulder height; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee must occasionally lift and / or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, depth perception, and ability to adjust focus.

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 moving mechanical parts, fumes or airborne particles, low levels of toxic or caustic chemicals, outside weather conditions, 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 3 / 29 / 2025