Job Description
Job Description
CordenPharma is a leading full-service Contract Development and Manufacturing Organization (CDMO) specializing in active pharmaceutical ingredients (APIs), excipients, drug products (DPs), and packaging. With around 3,000 employees worldwide, we help pharmaceutical, and biotech companies manufacture medicines with the ultimate goal of improving people’s lives.
Our network, spanning Europe and the U.S., provides flexible and specialized solutions across six technology platforms: Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, Small Molecules, and Oligonucleotides. We strive for excellence in supporting this network and are committed to delivering the highest quality products for patient well-being.
Our People Vision
We strive for excellence. We share our passion. Together, we make a difference in patients' lives.
SUMMARY
Provides Safety and Health leadership and consultation for large capital projects, ensuring that designs meet or exceed SHE regulatory requirements and company standards for Occupational Health & Safety, and Process Safety. Provides technical expertise for the SHE Team through knowledge of regulations and standards.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Include the following. Other duties may be assigned.
- Collaborates with capital project teams to ensure designs are compliant with Safety regulations, consistent with internal SHE standards, and that safety risks are mitigated. Specifically, reviews capital project designs to identify potential environmental, health, & safety impacts. Consults with Subject Matter Experts (SMEs) on the SHE Team, and collaborates with design teams to mitigate risk and ensure installations support SHE standards for worker safety
- Performs detailed review of OSHA, state, and city safety regulations, as well as codes and design standards, for applicability to new and existing installations
- Participates in project design reviews, including but not limited to: P&ID reviews, 3D model reviews, and as necessary, routine project meetings as Subject Matter Expert on site Safety and Health requirements
- Participates in risk assessment activities such as process hazard analyses, dust hazard analyses, and facility siting. Provides input on project actions to address outputs from these activities
- Serves as interface on SHE topics between Corden Pharma Colorado site and Project Management
- Supports and reviews the work of the Engineering partner on issues and deliverables related to safety on an ongoing basis to ensure work meets CPC standards. Provides input on work to meet safety regulatory requirements and Industry Best Practices to ensure solutions are suitable and aligned with CPC practice
- Acts as decision maker on Safety design questions for capital projects. Where appropriate, makes well-defined recommendations and escalates decisions to project or site management
LEADERSHIP & BUDGET RESPONSIBILITIES
Provide guidance and leadership where appropriate.
SAFETY & ENVIRONMENTAL RESPONSIBILITIES
Every individual is personally responsible for the safety and environmental aspects of their 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 Safety Engineering, Chemical Engineering, or related field is required. Ten years’ experience in Chemical Plant Process Engineering/Support functions is strongly preferred. Hands-on experience in a Pharmaceutical or Fine Chemicals Manufacturing environment, including Technical Safety, and/or Industrial Hygiene, responsibilities.
LANGUAGE SKILLS
Ability to read, analyze, and interpret common scientific and technical journals, and regulatory and compliance documents. Ability to effectively present information to management and colleagues.
MATHEMATICAL SKILLS
Competence in scientific mathematical skills and statistics, including metric analysis, trending, and reporting.
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
Certified Safety Professional 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 accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand and sit. The employee is occasionally required to walk; work with hands; reach above shoulder height; climb or balance; and stoop, kneel, crouch, or crawl. Specific vision abilities required by this job include close vision, distance vision, color vision, 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 wet and/or humid conditions, moving mechanical parts, and outside weather conditions. 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.
- Working knowledge of safety regulations and ability to apply regulatory letters of interpretation, in addition to other sound engineering practices consistent with recognized codes and standards. Ability to explain regulatory requirements and propose and defend and implement cost-effective solutions
- Working knowledge of OSHA’s Process Safety Management Program and its application to chemical manufacturing
- Working knowledge of applicable safety regulations. Ability to assess capital projects and identify the most effective solutions to minimize risk to employees through Best Practices in Safety
- Ability to evaluate facility and equipment changes for impact to worker safety and identify design improvements to reduce ergonomic and other safety risks
- Strong attention to detail, organization, and time management
- Excellent writing, interpretive, presentation, and interpersonal skills
- Analytical skills with the ability to function with interdisciplinary teams
- Proactive approach to problem-solving and resolution
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 Insurance
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 September 24, 2025