Quality Control Pharma Jobs in Colorado (NOW HIRING)

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Regular Full-Time Professional Boulder, CO, US

3 days ago Requisition ID: 1838

Salary Range: $105,000.00 To $120,000.00 Annually

CordenPharmais 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.

The Sr. Project Engineer is responsible for managing and executing projects in support of pharmaceutical drug substance, intermediates, and fine chemical development and production. The Sr. Project Engineer manages multiple, higher value 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.

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
• 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
• 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
• Develops and evaluates plans and criteria, for projects and activities, to be carried out by others. Secures resources for specific phases or aspects of project such as technical studies, system design, preparation of specifications and technical plans, construction, and qualification
• Leads timely resolutions of disputes & conflict resolution with external contractors, vendors, and stakeholders
• Oversees project qualifications, including operational performance, and ensures the delivery of the specified project performance
• 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; implementation logistics; resolving internal and external disputes; resolving engineering design and performance problems; construction supervision; building permits; and qualification and validation efforts

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 for ensuring that all major project objectives are met. Provides direction to contract engineers. Fosters a project team atmosphere that facilitates positive employee morale. Willingness to take on significant challenges and difficult assignments without the promise of special rewards or recognition.

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.

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.

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.

Bachelor's Degree in Chemical Engineering, Mechanical Engineering, or a related Engineering discipline from a 4-year college or university; along with 5 years related experience in the Pharmaceutical or Fine Chemical Industry, or a combination of education and experience.

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.

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.

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.

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 of this job.

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.

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, fumes or airborne particles, and noise typical of an office environment.

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 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
• Prioritization and organizational skills; proactive problem identification skills for technical, organizational, and personnel issues; management and resolution of conflicting priorities; and ability to delegate
• Knowledge of 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 include: 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; and 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
• Working knowledge and application of QSHE regulatory compliance principles related to chemical and pharmaceutical manufacturing, including FDA, cGMPs, EPA, OSHA, and PSM requirements
• 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; 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
• Participates in team decision making. Develops team problem-solving and communication skills. Capable of gathering input from stakeholders, seeking consensus and compromise, and informed decision making

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
• Critical Illness Insurance
• Disability Insurance
• Employee Assistance Program
• Flexible Spending Account
• Health Insurance PPO/HSA
• Hospital Indemnity Plan
• ID Theft Protection
• Life Insurance
• Tuition Reimbursement
• Wellness Program
• 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.