Sr. Project Engineer

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.

About the role

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.

Responsibilities

• 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.
• Provides leadership and management to assigned projects, 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.
• Adheres to safety and environmental responsibilities, performing job duties in a safe manner.
• Ensures compliance with Current Good Manufacturing Practices (cGMP) and other global regulations (FDA, ICH) to deliver quality objectives.

Requirements

• 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.
• Understanding of 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.
• Must be able to travel domestically and internationally.

Skills

• 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, including writing reports, proposals, and instructions incorporating both technical and business concepts; conducting briefings, presentations, and technical meetings; facilitating operator training and problem resolution; and representing Corden in negotiations with outside entities.
• 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.
• Knowledge of supporting departments’ procedures and systems, such as purchasing, management of change, and SAP.
• Understands the impact of 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 on the value of a project.
• 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, and is capable of gathering input from stakeholders, seeking consensus and compromise, and informed decision making.

Physical Demands

• 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

• 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.
• The employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, and noise typical of an office environment.

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