Job Description

Job Description

Job Description

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

This position is a support role in the Safety, Health, & Environment (SHE) Team through knowledge of regulations and safety standards; developing and implementing continuous improvements and management systems used in the manufacturing processes; and ensuring that SHE Safety goals are met. The Sr. Safety Engineer is responsible for the administration of policies to establish and promote the maintenance of a safe, accident free, and healthy work environment. Recommends and manages system improvements for compliance with Safety regulations and/or company policy.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Include the following. Other duties may be assigned.

• Provides day-to-day support to Manufacturing regarding Safety topics, at times requiring attention outside of normal business hours
• Conducts plant or area surveys to confirm safe limits of exposure to hazardous materials or conditions such as temperatures, noise, dusts, fumes, vapors, mists, gases, solvents, and radiation, which are known or suspected of being real or potential detriments to health. Implements or recommends control measures to prevent exposure and validates effectiveness of engineering controls
• Develops, implements, monitors, and continuously improves company-wide Safety programs in a variety of areas, such as confined space, electrical safety, lock-out tag-out, fall protection, fire protection, injury and illness recordkeeping.
• Conducts training and education for employees on various Safety topics
• Responsible for site emergency response activities as well as serving as the emergency coordinator for Brigade activities
• Conducts or coordinates safety equipment inspections, monitoring, and record keeping activities as required by permits or regulations. Ensures that all necessary files and records are maintained and retained in compliance with both corporate and legal requirements
• Provides a positive public image for Corden Pharma safety through interactions with the outside emergency response community and/or industry safety groups and programs, such as the Local Emergency Planning Committee (LEPC)
• Performs periodic safety inspections and compliance audits
• Reviews, investigates, and identifies resolution for Safety incidents
• Performs Root Cause Analysis of incidents, recommending corrective actions to minimize risk of future incidents
• Maintains Safety recordkeeping requirements in various Safety data management systems, including OSHA recordkeeping requirements
• Provides on-call technical support in case of site emergency
• Works with process and/or equipment design teams to design safe and environmentally compliant processes, minimizing Safety risks. Reviews and approves new or modified equipment designs and operating procedures

LEADERSHIP & BUDGET RESPONSIBILITIES

This job has no supervisory responsibilities. Responsible for defining; creating; and forecasting Safety Programs and equipment needs and cost; and for helping manage those costs to budget

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

Bachelor’s Degree in Chemical Engineering, Industrial Hygiene, Occupational Safety, or a related discipline. Ten years’ experience in chemical plant process support functions is strongly preferred. The ideal candidate will have hands-on experience in a Pharmaceutical or Fine Chemicals Manufacturing environment, including Safety and Industrial Hygiene responsibilities. RCA training and experience is required. TapRoot experience, is a bonus.

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 board 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

A recognized safety qualification, CSP, ASP, CHST or equivalent is preferred.

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 accommodation 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 sit and talk or hear. The employee is occasionally required to stand; walk; work with hands; reach above shoulder height; climb ladders; balance; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, depth perception, and ability to adjust focus. Occasionally required to wear a respirator in emergency response situations.

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.

The noise level in the work environment is that of a typical manufacturing plant, and the employee is exposed to typical environments encountered in a chemical manufacturing facility.

CORE COMPETENCIES

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

• Comprehensive knowledge of OSHA Safety regulations and ability to apply regulatory letters of interpretation. Ability to explain regulatory requirements and propose, defend, and implement cost-effective solutions
• Ability to analyze and recommend strategies for improving the work environment related to Safety while also understanding and supporting business objectives
• Technical writing skills, experience with spreadsheets, word processing, and databases
• Demonstrated technical competence and ability to learn new processes and technical subject matter; and the ability to identify innovative and practical solutions to complex problems
• Demonstrated skills in problem-solving, negotiations, initiative, and strong written and verbal communications with employees at all levels of the manufacturing organization. The ability to resolve problems with competing priorities and influence others to adopt the solutions in a collaborative manner
• Demonstrates problem analysis and troubleshooting skills; data compilation and simple analysis; and draw conclusions from data
• Works independently, decreasing reliance on mentors and supervisors to guide work and daily activities
• Demonstrates willingness to work in teams and to contribute in technical, plant support, and staff meetings
• Demonstrates emerging leadership skills and influence over others in small groups and small projects; knows and uses key facility contacts required to make progress on projects
• Ability to understand and apply statistical analysis to industrial hygiene monitoring events, and draw sound conclusions from the results
• Thorough working knowledge of regulatory issues in pharmaceutical manufacturing, including cGMPs, PSM, and OSHA are required
• Consistently demonstrates initiative in managing multiple projects and priorities

SALARY

Actual pay will be based on your skills and experience.

BENEFITS

• 401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service
• Accident Plan
• Critical Illness Insurance
• Dental Insurance
• Disability Insurance
• Employee Assistance Program
• Flexible Spending Account
• Health Insurance PPO/HSA
• Hospital Indemnity Plan
• ID Theft Protection
• Life Insurance
• Paid Paternal Leave
• Tuition Reimbursement
• Wellness Program
• Vacation – Three Weeks 1st Year
• Vision Insuranc

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.

This posting will expire on October 20, 2025

Job Tags

Contract work, Local area, Flexible hours,

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