Boulder, Colorado (US)
Corden Pharma Boulder is focused on the manufacture of highly potent Active Pharmaceutical Ingredients (APIs). We have a proven track record of moving processes for complex APIs from development into commercial production. We have the facilities, infrastructure and workforce to ensure the best chemistry is applied to our projects in the most compliant manner. Ultimately, in partnership with our customers, Corden Pharma Boulder is focused on its health care mission, proudly producing medicines that help patients around the globe survive and enjoy more comfortable lives.
Provides process engineering support for commercial or near-commercial manufacturing processes in assigned group or plant through developing and implementing continuous improvements in the production of bulk pharmaceutical intermediates and active pharmaceutical ingredients.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Establishes and maintains strong, transparent and effective day to day working relationships between manufacturing, maintenance & facilities, R&D, internal support, regulatory groups and CPC customers related to assigned duties.
- Provides day-to-day support to assigned processes, at times requiring attention outside of the normal work hours.
- 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.
- Assists with planning and execution of process changeovers.
- Develops and implements detailed plans for capital and expense projects.
- Creates and modifies support documents such as user requirements, equipment specifications, etc.
- Responsible for ensuring that hazardous and non-hazardous wastes streams are identified, characterized, and properly communicated to the environmental department.
- Supports manufacturing through writing, changing and maintaining production-related documentation, which includes batch records, change control, deviations, and investigations. Ensures that documentation is consistent with the process filing.
- Supports the growth and retention of knowledge capital via the process technical library by authoring lab, campaign, process investigation, process definition (control strategy), process optimization, and process fit reports.
- Process training – Writes and delivers training via PJT, process briefings, SOPs, guidelines, etc. to operations staff
- Contributes to meeting Process Safety Management compliance by participating in Process Hazard Analysis reviews, updating 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
This position is responsible for providing leadership and project management to 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 of their knowledge, training, ability and experience.
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 0-5 years’ experience in process engineering in a pharmaceutical or fine chemicals manufacturing environment.
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.
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.
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
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.
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.
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.
- 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
This is an exempt position. Salary based upon the successful candidate’s qualifications and level of experience.
Please refer to: Job #0519 – MS&T Engineer