Chemical Process Engineer

Corden Pharma Colorado• Boulder, CO, US, CO

4d•$91,000 - $114,000

About The Position

The Chemical Process Engineer performs research and development to transfer, design, and improve processes and technologies. The role provides process engineering support to manufacturing through continuous improvement, troubleshooting, and support for processes and equipment used to produce bulk pharmaceutical intermediates and active pharmaceutical ingredients (APIs). The position supports assigned processes in a 24/7 manufacturing environment, including work on the manufacturing floor and, at times, attention outside normal working hours. With supervisory oversight or input as applicable, the engineer evaluates process fit, develops and scales processes, supports technology transfer and validation, analyzes manufacturing data, authors and maintains process documentation, and helps resolve operational and product issues. The role works cross-functionally with Manufacturing, Quality Assurance, Quality Control, Validation, Engineering, Maintenance, and EHS. It contributes to safe and compliant manufacturing under cGMP, FDA, ICH, Process Safety Management, OSHA, EPA, and company quality-system requirements. The position also involves ongoing technical development and increasing ownership of assigned processes and projects.

Requirements

Bachelor’s degree in Chemical Engineering or a related technical field.
Demonstrated knowledge of Process Engineering fundamentals.
Ability to read, analyze, and interpret scientific and technical journals, financial reports, and legal documents, and to respond to inquiries or complaints from customers, regulatory agencies, or the business community.
Ability to write technical material and present information effectively to management, public groups, and boards of directors.
Ability to apply advanced mathematical concepts and statistical methods, including analysis of variance, correlation techniques, sampling theory, and factor analysis.
Ability to define problems, collect data, establish facts, draw valid conclusions, interpret technical instructions in mathematical or diagram form, and handle abstract and concrete variables.
Ability to meet the described physical demands, including occasionally lifting or moving up to 50 pounds.
Working knowledge or developing proficiency in plant-scale unit operations, scale-up, process safety, bulk API manufacturing, process engineering fundamentals, and process improvement methodologies.
Working knowledge of applicable compliance requirements, including cGMP, PSM, OSHA, EPA, and company quality systems.
Proficiency development with computer systems, including Microsoft Office, process modeling software, and statistical analysis programs such as Minitab or JMP.
Analytical and problem-solving skills, including data collection, trending, statistical analysis, investigations, and process performance evaluation.
Clear, concise written communication for technical reports, investigations, procedures, validation documentation, and campaign reports; ability to communicate technical information effectively in presentations and cross-functional discussions.
Ability to work effectively in cross-functional teams, show initiative and accountability, follow engineering standards and procedures, and seek guidance or escalation when appropriate.

Nice To Haves

Experience in chemical manufacturing, especially pharmaceutical bulk API production.
Equivalent combination of education and experience.

Responsibilities

Provide day-to-day support for assigned processes in 24/7 manufacturing, including floor support and, at times, attention outside normal working hours.
Evaluate whether new processes fit manufacturing needs, considering safety, cost, equipment, chemistry, and unit-operation technology, with supervisory oversight.
Perform process development using process modeling or laboratory-scale testing, focusing on critical scale-up parameters to transition from kilo-scale to full production scale; maintain accurate documentation and follow laboratory safety and quality practices.
Support technology transfer between manufacturing sites by assembling transfer packages, developing success plans, and implementing processes into manufacturing with supervisory oversight.
Analyze data and implement process improvements to reduce costs, improve yields, cycle times, and product quality, mitigate safety, health, and environmental risks, reduce downtime, and improve consistency and robustness.
Troubleshoot processes and conduct root cause analyses to resolve operational or product issues; support deviation closure and CAPA development.
Author and maintain master batch records, ensuring process requirements, equipment configurations, and documentation are accurate, executable, and compliant.
Author process training documentation and train operators.
Support process validation by authoring protocols and reports, participating in execution, and analyzing validation data for assigned process steps.
Monitor manufacturing operations and collect production data to identify anomalies, resolve issues in real time, evaluate process performance, and prepare campaign summary reports.
Support Process Safety Management compliance by participating in Process Hazard Analyses, risk assessments, and safety reviews, and by providing mass and energy balances and other engineering data.
Develop professional skills through on-the-job training, lectures, professional organizations, formal training, and conferences.
Support change control by evaluating proposed process, equipment, or procedural changes and assisting with implementation under quality systems.
Collaborate with Manufacturing, Quality Assurance, Quality Control, Validation, Engineering, Maintenance, and EHS to support safe, compliant, and efficient process execution.
As part of a cross-functional team, address Process Engineering requirements for assigned projects.

Benefits

401(k) matching: company contributes 100% of the first 6%, with 100% vesting 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.
Three weeks of vacation in the first year.
Vision Insurance.