Process Control Engineer Jobs in Colorado

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 to assigned processes, 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 via process modeling or testing at lab scale, concentrating on key scale up parameters to scale up from kilo-scale to full production scale
• Participates in technology transfer from one manufacturing site to another; develops plans for successful tech transfers, and implements processes into pilot or commercial facilities, with supervisory oversight. Assembles technology transfer packages
• Implements process improvements and optimization that reduce costs; improve yields, cycle times or product quality; resolve or prevent environmental, health and safety impacts; reduce down time; improve process consistency; and improve process robustness
• Performs process troubleshooting to resolve operating or product problems; identifies and implements solutions to improve process robustness
• Supports manufacturing through compiling technical requirements for batch record generation; providing technical input on equipment setup requirements; providing process training for operators; providing technical support in production for processes in development; writing process validation protocols; providing technical input on deviations and investigations; and writing campaign summary reports. Ensures that documentation is consistent with the process filing
• Contributes to meeting Process Safety Management compliance by participating in Process Hazard Analysis reviews; and by providing mass and energy balances and other engineering data for the assigned process
• Strives to improve professional skills by participating in on-the-job training, attending guest lectures, being an active member of a professional organization, and attending formal training courses and conferences

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 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.

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 1 year experience in Process 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 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

• Expands knowledge of plant-scale unit operations, scale-up, and plant design considerations; builds on technical knowledge in chemical engineering and process improvement methodology
• Emerging knowledge of regulatory issues in pharmaceutical manufacturing including cGMPs, PSM, OSHA, and EPA requirements
• Develops computer skills, in the areas of: Microsoft Office Products – Word, Excel, PowerPoint; Batch +, statistical analysis programs, and chemical engineering simulation software
• Explores training opportunities in technical areas that will strengthen skills for current assignments; acquires training to use common tools that support job (for example, Batch Plus)
• Regularly applies basic science and engineering principles to assigned projects
• Participates in and understands the importance of regulatory compliance systems such as PHAs and incident reporting; completes assignments, i.e., action items, in a timely manner
• Conducts basic technical and economic evaluations
• Demonstrates problem analysis and troubleshooting skills, data compilation, and simple analysis; draws conclusions from data
• Demonstrates a trend toward working independently – and decreasing reliance on mentors and supervisors to guide work and daily activities
• Executes assigned, well-defined tasks and seeks assistance when appropriate; and begins to offer some input on assigned projects
• Follows established methods and procedures; generally, implements existing standards and technical solutions; or implements new ideas that were generated by others
• Displays initiative to drive ideas or issues that he/she supports, and follow through to completion
• Understands and applies the Corden values
• Familiar with manufacturing department’s activities and Corden’s business goals and strategy
• Learns basics of project economics and product line cost structure and is familiar with the product standards manual
• Demonstrates clear, concise writing skills, targeting detailed reports on specific subjects, often requiring review by more senior personnel
• Presentation skills are developed through frequent ‘short and to the point’ presentations; generally targeting technical staff, process team, and project groups
• Demonstrates willingness to work in teams and to contribute in technical, plant support and staff meetings
• Demonstrates emerging leadership skills, and influence over others in small groups and small projects; knows and uses key facility contacts required to make progress on projects

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 protected by federal, state, or local laws. Corden Pharma embraces fair hiring practices.

This post will expire 7/24.