Principal Project Engineer

Job Description

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

The Principal Project Engineer is responsible for managing and executing capital projects in support of pharmaceutical drug substance, intermediates, and fine chemical development and production. The Principal Project Engineer manages multiple, high value, complex, projects over a diverse number of disciplines including civil; mechanical; equipment and facilities design and installation; technology transfer; and product delivery. Ensuring project cost, schedule and quality control, and adherence to regulatory laws and practices throughout the project life cycles are central to this position.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Include the following. Other duties may be assigned.

• Takes a lead role in working with the project owner and supporting staff to develop the project business case and project objectives. Ensures relevant alternatives are evaluated and the recommended solution is supported by local staff and management. Generates and communicates (i.e., presentations) and effectively builds consensus for proposals with project stakeholders as well as management
• Plans, develops, coordinates, and directs the entire engineering effort for assigned projects, ensuring project success. Directs efforts relating to the generation of cost estimates and capital requests. Manages the purchasing & contracting activities to ensure timely, cost-effective equipment and services are provided for the overall project. Proactively demonstrates responsibility for ensuring that cost, scope, and schedule requirements are met 
• Reviews project design for compliance with engineering principles, company standards, customer contract requirements, and related specifications. Leads the evaluation of the feasibility and soundness of proposed engineering designs and procedures. Performs as a staff advisor and consultant as to a technical specialty, a type of facility or equipment, or a program function (involving the integration of several business systems)
• Develops and evaluates plans and criteria for a variety of projects and activities to be carried out by others. Secures resources for specific phases or aspects of projects such as technical studies, system design, preparation of specifications and technical plans, construction, and qualification
• Leads timely resolutions of disputes and conflict resolution with external contractors, vendors, and stakeholders
• Project activities include, but are not limited to, user requirement specification input and review; scope development; process design; funding request preparations; evaluation of equipment system standards and specifications; project controls; overseeing change control process, implementation logistics; resolving internal and external disputes; resolving engineering design and performance problems; construction supervision; building permits; and qualification and validation efforts
• Interacts with customers as “Technical Lead” for Project Engineering concerns
• Provides updates (formal and informal) to Production Management and LT, as needed, regarding project progress, issues/issue resolution, and results

LEADERSHIP & BUDGET RESPONSIBILITIES

This position is responsible for providing leadership and management to assigned projects and is responsible for developing scopes, justifications, cost budgets, personnel requirements, and timelines to ensure that all major project objectives are met. Provides direction to contract engineers. Fosters a project team atmosphere that facilitates positive employee morale. The willingness to take on significant challenges and difficult assignments without the promise of special rewards or recognition.

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 (preferred), Mechanical Engineering, or a related engineering discipline from 4-year college or university; along with 10 years related experience in the Pharmaceutical or Fine Chemical Industry, 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 reports and proposals that conform to prescribed style and format. Ability to effectively present information to top management, public groups, and/or technical staff.

MATHEMATICAL SKILLS

Ability to comprehend and apply principles of advanced calculus, modern algebra, and advanced statistical theory. Ability to understand basic accounting and financial principles (ROI & IRR analysis, cashflow, committed vs. actual costs, etc.) as they apply to project management.

REASONING ABILITY

Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables.

CERTIFICATES, LICENSES, REGISTRATIONSNone.

TRAVELMust be able to travel domestically and internationally.

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 regularly required to talk or hear. The employee frequently is required to sit and work with hands. The employee is occasionally required to stand; walk; 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, 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 wet and/or humid conditions; moving mechanical parts; high, precarious places; outside weather conditions; extreme cold; and extreme heat. The noise level in the work environment is usually quiet. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, and fumes or airborne particles, and noise typical of an office environment. 

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.

• Demonstrated expert ability in engineering project management and construction management. Knowledge of project controls, including scheduling, budgeting, and change order systems. Proven ability in managing simultaneous projects of significant value
• Prioritization and organizational skills; proactive problem identification skills for technical, organizational, and personnel issues; management and resolution of conflicting priorities; and ability to delegate
• Comprehensive knowledge and expertise in specification; selection and purchasing equipment systems and materials used for bulk pharmaceutical chemicals; and specialty chemical processing
• Stays current with processing related equipment, technology, and innovations through regular reading of trade journals, contact with suppliers, and affiliation with professional organizations
• Communication skills across all levels of the organization including: writing reports, proposals, and instructions incorporating both technical and business concepts; conducting briefings, presentations, and technical meetings for internal and external representatives; facilitating operator training, debriefings, and problem resolution; providing oral presentations for leadership concerning business needs, project proposals, operations, and scheduling of specific phases of projects or contracts; representing Corden in negotiations with outside entities to ensure best terms and conditions 
• Ability to carry out engineering calculations related to process/equipment design
• Knowledge of qualification and validation systems, including test protocols, execution, and reports
• Thorough working knowledge and application of QSHE regulatory compliance principles related to chemical and pharmaceutical manufacturing, including FDA, cGMPs, EPA, OSHA, and PSM requirements
• Has a working knowledge of business and finance; basic accounting and financial principles (ROI & IRR analysis, cashflow, committed vs. actual costs, etc.) as they apply to project management; demonstrates vision of future business direction and needs; drives results which have major economic impact on the site’s profitability
• Knowledge of supporting departments’ procedures and systems, such as purchasing, management of change, and SAP 
• Understands the impact of the following on the value of a project: life cycle ROI, future processing benefits, financial impacts on the business, regulatory compliance, physical implementation logistics, internal team, and corporate approaches, as well as external community needs 
• Able to generate and implement novel ideas and methods to meet both site and project needs
• Ability to analyze situations and anticipate impact of decisions

 

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