CordenPharma Job Opportunity 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. We strive for excellence. We share our passion. Together, we make a difference in patients' lives.
Job Summary:
Operates process wastewater treatment; monitors the two Thermal Oxidizers; troubleshoots utilities; and collects, inspects and disposes of site generated wastes. Performs analyses to monitor performance of treatment systems and to document compliance with permitted discharges by performing the following duties detailed below.
Essential Duties and Responsibilities:- Include the following. Other duties may be assigned.
- Perform monitoring, troubleshooting, recording, and analysis of treated and untreated production area wastewater to meet pre-treatment discharge permit requirements
- Use of a variety of analytical laboratory equipment, multi-step procedures, as well as tracking QA/QC for analytical tests
- Monitor and troubleshoot the Thermal Oxidizers 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
- Manage hazardous and nonhazardous plant waste. Including but not limited to shipping and receiving, storing, and tracking of all waste according to all regulations and requirements. Evaluate waste for disposal options, identify labeling and manifest requirements, and prepare disposal profiles
- 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 on evenings and weekends; provide back-up support for utilities tasks as assigned; troubleshoot identified problems; and assist with re-starting after outages
- Perform storm water samples and discharges in compliance with permit requirements
- Follow up on employee odor complaints and perform spill/release cleanups for disposal. Other duties may be assigned
- Collect, label, and submit/ship pre-treatment permit required wastewater 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
- Perform or coordinate Health and Safety periodic safety equipment inspections to include, but not limited to, ladders, fire extinguishers, safety showers and eye wash fountains, safety signage, confined space equipment, and solvent cabinets. Other duties to support Health and Safety may be assigned
- Personnel will need to periodically provide coverage on other shifts including both night and day shifts, as required by needs of the area
- Leadership & Budget Responsibilities
None.
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 High School Diploma or General Education Degree (GED) and 3 years related experience; or equivalent combination of education and experience. Previous experience in Wastewater, Industrial Chemical, or Utilities Operations is preferred.
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 SkillsAbility 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, RegistrationsDOT Hazardous Materials Transportation & RCRA Hazardous Waste Management (HAZWOPPER) Certification required within 6 months of hire Forklift Certification (provided upon hire) 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.
- Ability to operate WWTP within all compliance parameters. Ability to operate thermal oxidizer 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 SOPs, 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 perform all laboratory analytical tests, including those typically done at night
- Use of database and spreadsheets including data entry, report compilation, and data review to
