What are the responsibilities and job description for the Principal Environmental Engineer position at Corden Pharma - A Full-Service CDMO?
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
This position provides leadership to the Sr. Environmental Operators. Responsible for the effective execution of operations required to maintain reliable equipment and compliance systems in the Environmental Operations area. Additionally, performs other tasks to support Environmental Operations such as waste disposal profiling, groundwater treatment, and monitoring. This position will work 5 days per week, Monday through Friday, providing shift coverage when needed.
Essential Duties And Responsibilities
Include the following. Other duties may be assigned.
This job has no direct supervisory or budget responsibilities; however, there is responsibility for training other operators in proper techniques. Principal Operators will, as needed, function as the Lead Environmental Operator during absences.
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
Requirement to be a Sr. Environmental Operator in good standing. High School Diploma or General Education Degree (GED) and three years related experience; or equivalent combination of education and experience.
Language Skills
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to work effectively with other departments and outside agencies for waste transfers, waste shipments, spill collection, and training.
Mathematical Skills
Ability to calculate figures and amounts such as proportions, percentages, area, circumference, dilutions, and volume. Ability to apply concepts of basic math, algebra and geometry
REASONING ABILITY
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
CERTIFICATES, LICENSES, REGISTRATIONS
DOT Hazardous Materials Transportation & RCRA Hazardous Waste Management. (HAZWOPPER) certification required. Forklift Certification. Ability to drive and operate the vacuum truck. Rescue Certification 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 frequently required to stand; walk; work with hands; reach above shoulder height; climb or balance; stoop, kneel, crouch, or crawl; and talk or hear. The employee is occasionally required to sit 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, color vision, peripheral 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 frequently exposed to moving mechanical parts and outside weather conditions. The employee is occasionally exposed to high, precarious places; fumes or airborne particles; low levels of toxic or caustic chemicals; extreme heat; 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.
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.
SALARY
Actual pay will be based on your skills and experience.
Benefits
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 provides leadership to the Sr. Environmental Operators. Responsible for the effective execution of operations required to maintain reliable equipment and compliance systems in the Environmental Operations area. Additionally, performs other tasks to support Environmental Operations such as waste disposal profiling, groundwater treatment, and monitoring. This position will work 5 days per week, Monday through Friday, providing shift coverage when needed.
Essential Duties And Responsibilities
Include the following. Other duties may be assigned.
- Lead the weekday shifts by coordinating daily work in the Environmental Operations area, as assigned by the Lead Environmental Operator
- Work with maintenance as needed to coordinate completion of maintenance work in the area
- Coordinate Chemical Operator support
- Coordinate and/or assist with site soil excavation projects, including identifying hazards, drafting excavation plan, approving excavation permits, drafting excavation health and safety plan, and arranging for the proper storing and testing of soils for proper disposal
- Perform monitoring, troubleshooting, recording, and analysis of treated and untreated production area wastewater to meet pre-treatment permit requirements. Performance of analyses involves the use of a variety of analytical equipment, multi-step procedures, as well as tracking QA/QC for these tests
- Monitor and troubleshoot the Thermal Destructive Device and evaluate the operation to prevent downtime. Assist in performing preventative maintenance including preparation for service, cleaning of equipment, filter changes, and other duties as required
- Complete management of hazardous and nonhazardous plant waste. Including but not limited to shipping and receiving, storing, and tracking of all waste according to all permits and requirements. Evaluate wastes for disposal options, identify labeling requirements, and prepare disposal profiles. Work with waste disposal vendors to create and update waste profiles
- Coordinate and/or perform weekly RCRA satellite inspections. Repair/report any abnormalities under RCRA regulations
- Perform tasks to support the Corden Pharma Groundwater Program, including sampling and monitoring/maintenance of the treatment equipment
- Coordinate Corden’s Groundwater Program periodic monitor well sampling
- Ensure area housekeeping and operability is maintained and verify proper inventories of lab reagents and required equipment; and see that they are ordered as needed. Perform area walkthroughs, making note of condition including heat trace, insulation, and equipment status
- Monitor operation of site utilities as needed, troubleshoot identified problems, and assist with re-starting after outages
- Perform storm water discharges, odor investigations, and spill/release cleanups for disposal
- Collect, label and submit/ship pre-treatment permit required samples for external lab analysis
- Perform lab and treatment equipment preventative maintenance and coordinate repairs. Implement improvements which are identified and approved
- Review modified analysis and job procedures for approval; ensure documentation used in area is current with document revision
- Responsible for properly managing the generation and accumulation of hazardous and non-hazardous waste
- Personnel will need to periodically provide coverage on other shifts including both night and day shifts as required by the needs of the area
This job has no direct supervisory or budget responsibilities; however, there is responsibility for training other operators in proper techniques. Principal Operators will, as needed, function as the Lead Environmental Operator during absences.
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
Requirement to be a Sr. Environmental Operator in good standing. High School Diploma or General Education Degree (GED) and three years related experience; or equivalent combination of education and experience.
Language Skills
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to work effectively with other departments and outside agencies for waste transfers, waste shipments, spill collection, and training.
Mathematical Skills
Ability to calculate figures and amounts such as proportions, percentages, area, circumference, dilutions, and volume. Ability to apply concepts of basic math, algebra and geometry
REASONING ABILITY
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
CERTIFICATES, LICENSES, REGISTRATIONS
DOT Hazardous Materials Transportation & RCRA Hazardous Waste Management. (HAZWOPPER) certification required. Forklift Certification. Ability to drive and operate the vacuum truck. Rescue Certification 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 frequently required to stand; walk; work with hands; reach above shoulder height; climb or balance; stoop, kneel, crouch, or crawl; and talk or hear. The employee is occasionally required to sit 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, color vision, peripheral 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 frequently exposed to moving mechanical parts and outside weather conditions. The employee is occasionally exposed to high, precarious places; fumes or airborne particles; low levels of toxic or caustic chemicals; extreme heat; 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.
- Strong leadership and delegation skills
- Ability to operate WWTP and groundwater treatment system within all compliance parameters. Ability to operate TDD within all compliance parameters. This includes the ability to start, stop, and prepare equipment for maintenance
- Ability to accurately and thoroughly record data as it relates to FOPs, PJTs, EGMs and other regulatory documentation including Quality Assurance Systems
- Ability to isolate, LOTO, and write work permits for a variety of operating equipment. This work may involve using a harness to access high locations and breaking flange connections at some locations
- Ability to analyze problems, determine root cause, and develop and implement solutions. Perform operational PMTs to maintain area equipment
- Ability to coordinate waste shipments, waste collection, waste transfers, and other activities with outside contract or vendors. Ability to generate and modify waste profiles
- Ability to perform all laboratory analyses tests, including those testing requirements set forth by the City Industrial Wastewater Discharge Permit
- High level of demonstrated aptitude in the use of databases and spreadsheets including data entry, report compilation, and data review to ensure compliance
- Use of RS3, Delta V, and custom computer packages to manage process and monitoring equipment
- Thorough knowledge of hazardous waste rules/regulations, disposal options, audit procedures, Corden standards for acceptable handling and disposal of waste, and proper documentation
- High level of technical troubleshooting skills in all areas of wastewater treatment
- Ability to identify proper labeling and disposal options for waste
- Strong interpersonal skills and knowledge of appropriate procedures to effectively deal with outside regulatory agencies and resolve issues
- Ability to train on technical aspects of the treatment process
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.
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 Maternity/Paternity Leave
- Tuition Reimbursement
- Wellness Program
- Vacation – Three Weeks 1st Year
- Vision Insurance
Salary : $127,707 - $147,927