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 VisionWe strive for excellence. We share our passion. Together, we make a difference in patients' lives.

SUMMARY

The Project Engineer is responsible for managing and executing capital projects in support of pharmaceutical drug substance, intermediates and fine chemical development and production. The project engineer manages multiple, high-value projects over a diverse number of disciplines including civil; mechanical; equipment & facilities design & 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. Major and complex tasks will be performed with supervisory oversight.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Include the following. Other duties may be assigned.

• Works with the project owner and supporting staff to develop the project business case and project objectives. Helps with the development of relevant alternatives; and supports their evaluation and that the recommended solutions are supported by local staff and management. Helps generate and communicate (i.e., presentations) and effectively build consensus for proposals with project stakeholders, as well as management
• Plans, develops, and coordinates engineering efforts, with supervisory oversight, for projects while ensuring project success. Supports efforts relating to the generation of cost estimates, as well as cost and schedule tracking. 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. Supports the evaluation of the feasibility and soundness of proposed engineering designs and procedures
• Supports evaluation of plans and criteria for a variety of projects and activities to be carried out by others. Helps to secure resources for specific phases or aspects of projects, such as technical studies, system design, preparation of specifications and technical plans, construction, and qualification
• 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; supporting process design concepts; funding request preparations; evaluation of equipment system standards and specifications; project controls; overseeing change control process; implementation logistics; assisting in resolution of internal and external disputes; assisting in resolving engineering design and performance problems; construction supervision; building permits; and qualification and validation efforts.

LEADERSHIP & BUDGET RESPONSIBILITIES

This position is responsible for supporting assigned projects and 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.

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

Bachelor's Degree (BS) in a scientific discipline, Chemical Engineering preferred; with 1 year of related experience and/or training.

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.). Ability to deal with a variety of abstract and concrete variables.

CERTIFICATES, LICENSES, REGISTRATIONS

None.

TRAVEL Ability to travel domestically and internationally may be required.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 may 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. 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 and manufacturing environments.

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.

• 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 and understanding in specification, selection, and purchasing equipment systems and materials used for bulk pharmaceutical chemicals and specialty chemical processing
• Strong written and verbal communication skills. Frequent contacts with personnel at various management levels concerning operations or scheduling of specific phases of projects or contacts. Conducts briefings and technical meetings for internal and external representatives concerning specific operations. Ability to effectively write reports, proposals and instructions incorporating both technical and business concepts
• Ability to carry out engineering calculations related to process/equipment design
• Knowledge of qualification and validation systems, including test protocols, execution, and reports
• Emerging knowledge of regulatory issues in pharmaceutical manufacturing, including cGMPs, PSM, OSHA, and EPA requirements
• Has a working knowledge of business and finance; basic accounting and financial principles (ROI & IRR analysis, cash flow, committed vs. actual costs, etc.) as they apply to project management; helps to drive results which have major economic impact on the site’s profitability
• Participates in team decision making. Helps to develop 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
• 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 August 07, 2026