Principal Chemical Process Engineer

CordenPharma Colorado
Colorado (US)
Job #1934
Full-time

CordenPharma Colorado
Job #1934

Boulder, Colorado (US)
Full-time

CordenPharma Colorado

CordenPharma Colorado is a highly sophisticated and entrepreneurial mid-sized pharmaceutical manufacturing company located in Boulder, Colorado. Our chemists and engineers are widely recognized for their history of innovation, having developed efficient manufacturing processes for some of the world’s most complex pharmaceutical compounds. CordenPharma Colorado also is acclaimed for its flexible manufacturing facilities and experienced workforce that can handle a wide range of production techniques and volumes. Ultimately, in partnership with our customers, CordenPharma Colorado is focused on its health care mission, proudly producing medicines that help patients around the globe survive and enjoy more comfortable lives.

OUR MISSION

Support our customers, leading pharmaceutical and biotechnology companies, in full and on time (DIFOT) with products and services. Our ultimate stakeholders and beneficiaries are naturally the patients in critical need of the sophisticated medications we manufacture.

We should never forget that the work we all do as an organization is critical to patients and ultimately improves peoples’ lives. There lies our right for existence, challenge, opportunity and motivation that should drive each of us individually at your respective sites and us together company-wide across the entire network.

SUMMARY

The Principal Chemical Process Engineer provides strong, technical leadership and documentation in the area of process development and manufacturing process support in assigned group or plant. Researches, develops and implements new and innovative process chemistry, engineering and technology that significantly improve the environment, safety and cost aspects of manufacturing. Interacts with management in developing project objectives, department goals and site concepts & strategies; advises management regarding technical opportunities and advances.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.
Other duties may be assigned.

  • >>  Provides day-to-day support to manufacturing and process development, at times requiring attention outside of the normal work hours. Support includes troubleshooting and continuous improvement of equipment and processes as well as participation in change control, deviations, and investigations.
  • >>  Leads interdisciplinary teams that identify, evaluate, develop and implement process improvements and optimization that: ensure process robustness; reduce costs; improve yield, cycle times and product quality; resolve or prevent environmental, health and safety impacts; reduce down time; and improve process consistency.
  • >>  Evaluates new process fits into manufacturing equipment; has good grasp of process fit issues – safety factors, standard cost, equipment, chemistry, unit operations.
  • >>  Leads technology transfers in preparation for process scale up / manufacturing; develops and implements innovative process scale-up technologies.
  • >>  Develops and implements detailed technical plans for large projects, including successful technology transfers, providing leadership and technical project management.
  • >>  Leads process validation efforts, including control strategy development, validation strategy/master plan, validation protocol development, and validation assessment / reports.
  • >>  Initiates and follows through on the development and implementation of new and innovative process chemistry, engineering and technology that significantly improve the environment, safety and cost aspects of manufacturing.
  • >>  Participates in setting production standards; Responsible for participating in the budget process for large scale technology transfers and/or research projects.
  • >>  Supports manufacturing through authoring operating procedures, SOPs, guidelines, PSI packages, process models, process validation documents, and participates in the assembly of technology transfer packages.
  • >>  Supports the growth and retention of knowledge capital via the process technical library by authoring lab, campaign, process investigation, process optimization, and process fit reports. Ensures that documentation is consistent with the process filing.
  • >>  Coaches, mentors and trains less experienced engineers and other operations personnel on technical and business issues; encourages excellence by others to operate following the Corden’s values and through positive feedback for good technical and team work

LEADERSHIP & BUDGET RESPONSIBILITIES

Provides technical leadership for cross functional technical teams on development projects. Coaches, mentors and trains less experienced engineers.

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 of 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

Minimum of a BS in Chemical Engineering and minimum of 10 years’ experience of demonstrated success in process engineering in a pharmaceutical chemicals manufacturing environment (partial experience in pharmaceutical drug products or fine chemicals manufacture will be considered)

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

Not mandatory.

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, sit, and talk or hear. The employee is occasionally required to work with hands; reach above shoulder height; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 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.

  • >>  Broad technical expertise in chemical engineering and process improvement methodology.
  • >>  Thorough knowledge of plant scale unit operations, scale-up, and plant design considerations.
  • >>  Broad understanding of chemical reactivity, potential exotherms, cross-reactivity, side products and waste streams.
  • >>  Thorough working knowledge and application of QEH&S regulatory compliance principles related to chemical and pharmaceutical manufacturing including FDA, cGMPs, EPA, OSHA and PSM requirements.
  • >>  Ability to understand and apply statistical design of experiments and draw sound conclusions from the results; uses results when solving problems, or proposing improvements.
  • >>  Computer skills, in the areas of: Microsoft Office Products – Word, Excel, PowerPoint; Batch +, statistical analysis programs, and chemical engineering simulation software.
  • >>  Stays current with processing-related equipment, technology and innovations through regular reading of trade journals, contact with suppliers and affiliation with professional organizations.
  • >>  Seeks opportunities to learn manufacturing needs and methods that facilitates substantial process improvements; acquires new skills in state-of-the art technology and applies it to their assignments.
  • >>  Establishes and maintains external technical contacts.
  • >>  Sought for high profile projects, advice/consulting, or problem solving; recognized for high levels of creativity and technical expertise.
  • >>  Routinely demonstrates a proactive approach to problem identification and resolution.
  • >>  Understands Corden’s business goals and contributes technically to its strategy development.
  • >>  Demonstrated ability to interact with management in developing project objectives and site strategies; advise management regarding technical opportunities and advances.
  • >>  Demonstrated communication skills (presentation, persuasion, written, oral) across all levels of the organization. Prepares clear and well organized reports on extensive, independent work. Produces entirely self-generated presentations for audiences including upper management, and outside of the site.
  • >>  Demonstrated ability to lead other technical personnel (engineers, chemists, operations personnel) in successful planning and execution of technical/development projects.

SALARY

This is an exempt position. Salary based upon the successful candidate’s qualifications and level of experience.

Application

To apply, please click on the “Apply Here” button. An email box will open to forward a copy of your resume to our Human Resources department for review. Please include the job number and title in the subject line:

Job #1934 – Principal Chemical Process Engineer

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