Principal Environmental Engineer

Corden Pharma 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

Provide strong, technical leadership and documentation in the area of environmental engineering to support manufacturing processes. This includes developing and implementing continuous improvements and management systems used in the production of bulk pharmaceutical intermediates and organic chemicals. Ensure that all QSHE goals are met.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Include the following. Other duties may be assigned.

• Leads interdisciplinary teams that identify, evaluate, and implement SHE programs that reduce costs, improve yields or cycle times, improve product quality, resolve or prevent safety, health, environmental impacts, reduce down time, and improve process consistency
• Leads troubleshooting teams to resolve SHE related regulatory problems
• Reviews new regulations, determines applicability to Corden, and implements necessary compliance systems. Submits periodic government reports as required
• Performs measurements and/or calculations to determine waste and or emission volumes from site activities
• Works with process and/or equipment design teams to design environmentally friendly processes. Reviews and approves new or modified equipment designs and operating procedures
• Negotiates and communicates with regulatory agencies to obtain permits to construct and operate new equipment or processes and in compliance/noncompliance situations
• Provides technical resources for the Environmental Team
• Conducts monitoring and record keeping activities as required by permits or regulations. Reviews environmental data collected by instruments, software packages etc. Writes environmental SOPs as required
• Provides general back-up support for safety issues, with a particular focus on capital projects and operating procedures
• Evaluates new chemical manufacturing relative to environmental and regulatory risks and recommends action for modification as necessary
• Responsible for properly managing the generation and accumulation of hazardous and non-hazardous waste
• Coaches, mentors, and trains less experienced engineers and other operations personnel on technical and business issues
• Makes presentations to community forums
• Assists with Corporate reporting such as the annual sustainability report

LEADERSHIP & BUDGET RESPONSIBILITIES

When assigned as a Team Leader, supervises technicians, engineers, and operators as appropriate. Supports the site Responsible Care® Program as designated by the site Responsible Care® Coordinator.

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

A BS in Chemical Engineering and 10 years’ experience of demonstrated success in Environmental Engineering in a Pharmaceutical or Fine Chemicals Manufacturing environment.

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 regularly required to sit; work with hands; and talk or hear. The employee is occasionally required to stand; walk; 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 25 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.

• Ability to provide leadership in all Environmental Engineering aspects of Environmental affairs
• Ability to provide leadership in an interactive, interdisciplinary team environment
• Proactive approach to problem identification and resolution
• Strong verbal and written communication skills
• Thorough knowledge of plant scale unit operations, scale-up, and plant design considerations
• Ability to understand and apply statistical design of experiments and draw sound conclusions from the results
• Broad technical expertise in chemical engineering and process improvement methodology
• Thorough working knowledge of regulatory issues in pharmaceutical manufacturing