Sr. Process Safety Engineer

Sr. Process Safety Engineer

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.

The Sr. Process Safety Engineer provides process safety engineering technical expertise and leadership to ensure Corden facilities are operated in a manner that protects the health and safety of employees and the public; protects the environment; and provides regulatory compliance.

Collectively, the position will encompass process safety through all phases of the process (design, installation, operation, decommissioning, maintenance, and training) including manufacturing, processing, handling, and storing of hazardous chemicals. Priority will be placed on creating, executing, and maintaining systems that provide the foundation for the proactive identification, evaluation, and mitigation/prevention of chemical releases that could occur as a result of failures in processes, procedures, or equipment.

Essential Duties And Responsibilities

Include the following. Other duties may be assigned.

• Provide functional support and guidance for PSM elements under the ownership of other departments
• Develop and deliver PSM-required employee training. Establish means and methods for sharing relevant safety knowledge and lessons learned from industry experience. Develop the necessary process safety expertise, judgment, and initiative within the Corden workforce to continually strengthen the Process Safety Program
• Implement, maintain, and continuously improve process safety policies, procedures, and systems. Ensure that the established PSM Program also meets the business needs of Corden. Establish relationships with other process safety resources within and outside of Corden to gain additional knowledge of industry practices, and to provide guidance and knowledge in return
• Provide process safety technical and regulatory expertise to all Corden employees
• Establish, maintain, and enhance systems for managing change so that the safety and risk controls originally designed into the facility are maintained or enhanced
• Develop and implement systems for identifying, evaluating, and mitigating/preventing hazards to human life, the environment, and/or the business
• Maintain the program to periodically assess all aspects of the PSM Program to ensure it meets site and regulatory requirements. Develop a system for addressing any identified deficiencies
• Lead risk assessment and incident investigation teams and follow implementation of recommendations
• Identify and coordinate needed physical testing of new raw materials, isolated and non-isolated intermediates, and final products for hazards data. Develop systems for safely handling and using hazardous materials in conjunction with process resources

Leadership & Budget Responsibilities

None.

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 Chemical Engineering from a 4-year college or university is required. Five years' experience in Chemical Plant Process Engineering/Support Functions, including 3 years of direct experience with Process Safety responsibilities. Hands-on experience in a Manufacturing environment including process safety responsibilities.

Language Skills

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

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 sit and talk or hear. The employee is occasionally required to stand; walk; work with hands; reach above shoulder height; climb or balance; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 25 pounds.

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, skills, and abilities that are important for successful job performance. They must be job related and consistent with business necessity.

• Ability to provide leadership in all process safety aspects of manufacturing processes
• Coaches, mentors, and trains less experienced engineers and other operations personnel on PSM subjects
• Demonstrated ability to develop a range of engineering options for compliance that will allow the company to develop a PSM Program that addresses site specific needs
• Process Hazard Analysis Leader training and demonstrated ability to effectively lead Process Hazard Analysis Teams
• Experience with process engineering support for chemical manufacturing processes
• Strong working knowledge with OSHA's 1910.119 standard and regulatory letters of interpretations in addition to other sound engineering practices consistent with recognized codes and standards. Ability to read, understand, and explain regulatory documents and propose, defend, and implement cost-effective solutions
• Demonstrated technical competence and ability to learn new processes, technical subject matter, and ability to apply broad technical knowledge to solve specific problems
• Demonstrated hands-on approach: emphasizing cost effectiveness and high-quality standards
• Results oriented: ready and willing to accept and fulfill challenging problem-solving responsibilities
• Strong written and verbal presentation skills: Prepares clear and well-organized reports on extensive independent work. Provides presentations for audiences, both inside and outside of the company, including upper management and customers
• Demonstrated ability to manage several complicated projects concurrently
• Demonstrated understanding to explain/articulate the PSM requirements to others within the company who need to understand PSM issues
• Demonstrated skills in problem-solving; negotiations; initiative; and strong written and verbal communications with employees at all levels of the organization. The ability to resolve complex problems with competing priorities; and influence others to adopt the solutions