Chemical Process Engineer
hace 10 días
Boulder
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 Performs research and development activities for the purpose of transferring and designing/improving a process or technology. Provides process engineering support for manufacturing processes in assigned group or plant through developing and implementing continuous improvements. And through troubleshooting methods and equipment used in the production of bulk pharmaceutical intermediates and active pharmaceutical ingredients. ESSENTIAL DUTIES AND RESPONSIBILITIES Include the following. Other duties may be assigned. • Provides day-to-day support for 24/7 manufacturing to assigned processes including support on the manufacturing floor, at times requiring attention outside of the normal work hours, • Evaluates new process fits into manufacturing with supervisory oversight, including consideration of safety, cost, equipment, chemistry, and unit operation technological needs, • With supervisory input, performs process development using process modeling or laboratory scale testing, focusing on critical scale up parameters to transition from kilo-scale to full production scale. Demonstrates and promotes Good Laboratory Practices by maintaining accurate documentation, adhering to laboratory safety procedures, and ensuring compliance with quality standards, • Supports technology transfer between manufacturing sites. Assembles technology transfer packages, develops plans for success, and implements processes into manufacturing with supervisory oversight, • Performs data analysis to identify and implement process improvements and optimizations that reduce costs; improve yields, cycle times, and product quality; mitigate safety, health, and environmental risks; reduce downtime; improve process consistency; and enhance process robustness, • Conducts process troubleshooting and root cause analyses to resolve operational or product issues, supporting deviation closure and Corrective and Preventative Actions (CAPA) development, • Authors and maintains master batch records, ensuring process requirements, equipment configurations, and documentation are accurate, executable, and compliant with quality and regulatory requirements, • Authors process training documentation for operations and provides training for operators, • Supports process validation activities, including authoring protocols and reports, participating in execution activities, and analyzing validation data for assigned process steps, • Monitors manufacturing operations and collects production data to identify anomalies, support real-time issue resolution, evaluate process performance, and author campaign summary reports, • Contributes to Process Safety Management compliance by participating in Process Hazard Analyses, risk assessments, and safety review; providing mass and energy balances; and supplying other engineering data for assigned processes, • Seeks to enhance professional skills through on-the-job training, attending lectures, active participation in professional organizations, and attending formal training courses and conferences, • Supports change control activities by evaluating proposed process, equipment, or procedural change and assisting with implementation in accordance with quality systems, • Collaborates with Manufacturing, Quality Assurance, Quality Control, Validation, Engineering, Maintenance, and EHS personnel to support safe, compliant, and efficient process execution LEADERSHIP & BUDGET RESPONSIBILITIES As part of a cross functional team, this position is responsible and accountable for addressing Process Engineering requirements for assigned projects. 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 or a related technical field. Demonstrated knowledge of Process Engineering fundamentals is required; experience in Chemical Manufacturing, especially Pharmaceutical Bulk API Production, is preferred; or equivalent combination of education and experience. 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 frequently required to stand, sit, and talk or hear. The employee is occasionally required to walk; work with hands; 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 50 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. • Develops knowledge of plant-scale unit operations, scale-up, process safety, and bulk API manufacturing operations while building proficiency in chemical engineering fundamentals and process improvement methodologies, • Demonstrates working knowledge of applicable regulatory and compliance requirements, including current Good Manufacturing Practices (cGMP), Process Safety Management (PSM), OSHA, EPA, and company quality systems, • Develops proficiency with computer systems, including Microsoft Office applications, process modeling software, and statistical analysis programs (e.g. Minitab, JMP), • Pursues professional development through on-the-job learning, technical training, professional organizations, conferences, and other growth opportunities, • Applies fundamental scientific and engineering principles, using them to analyze process performance, interpret data, support troubleshooting efforts, perform technical and economic evaluations, and contribute to the development of practical, technically sound solutions, • Understands and participates in compliance systems such as PHAs, incident reporting and investigations, deviations, and CAPAs, • Demonstrates analytical and problem-solving skills through effective data collection, trending, statistical analysis, investigations, and process performance evaluation, • Demonstrates initiative, accountability, and follow-through in completing assignments, resolving issues, and supporting project objectives all while balancing defined schedules and priorities, • Demonstrates increasing ownership of assigned processes, projects, and responsibilities while progressing toward greater technical independence, • Executes assigned engineering tasks and seeks guidance, collaboration, or escalation when appropriate; begins to offer some input on assigned projects, • Follows established engineering standards, methodologies, and procedures; while contributing new ideas that will improve process or business systems, • Demonstrates Corden values and supports departmental and organizational objectives, • Understands basics of project economics and product line cost structure and supports costing and production Bill of Materials (BOMs), • Demonstrates clear, concise written communication skills, targeting technical reports, investigations, procedures, validation documentation, and campaign reports, • Communicates technical information effectively through presentations, discussions, and interactions with other departments, within project teams, and occasionally with external customers, • Works effectively in cross-functional teams and contributes to technical discussions, plant support activities, project teams, and continuous improvement or operational excellence initiatives, • Demonstrates emerging leadership skills through participation in small projects, coordination of activities, and positive influence within teams 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 Parental 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 p
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