Sr. Project Engineer

Corden Pharma - A Full-Service CDMO• Boulder, CO, US, CO

83d•$105,000 - $120,000

About The Position

The Sr. Project Engineer manages and executes projects supporting pharmaceutical drug substance, intermediates, and fine chemical development and production. The role manages multiple high-value projects across disciplines including civil and mechanical engineering, equipment and facilities design and installation, technology transfer, and product delivery. The position is accountable for project cost, schedule, and quality control, as well as adherence to regulatory laws and practices throughout project life cycles. The Sr. Project Engineer leads project planning and execution with project owners, supporting staff, contractors, vendors, and stakeholders. Responsibilities include developing business cases and objectives, evaluating alternatives and engineering designs, coordinating engineering work, securing resources, managing purchasing and contracting, overseeing qualifications, and ensuring specified project performance. The position also provides leadership to assigned project teams and direction to contract engineers. The role supports pharmaceutical manufacturing conducted in accordance with cGMP, FDA, ICH Q7, and other applicable global regulations. Domestic and international travel is required. The work environment is usually quiet, with occasional exposure to wet or humid conditions, moving mechanical parts, heights, outdoor weather, extreme temperatures, fumes or airborne particles, and office-environment noise. The role includes regular talking or hearing, frequent sitting and hand use, occasional standing, walking, reaching, climbing or balancing, stooping, kneeling, crouching, crawling, tasting or smelling, and occasionally lifting or moving up to 50 pounds.

Requirements

Bachelor's degree in Chemical Engineering, Mechanical Engineering, or a related engineering discipline from a four-year college or university, along with 5 years of related experience in the pharmaceutical or fine chemical industry; a combination of education and experience may be accepted.
Demonstrated ability in engineering project management and construction management; knowledge of project controls, including scheduling, budgeting, and change-order systems; ability to manage simultaneous projects.
Prioritization, organizational, delegation, and proactive problem-identification skills, including management and resolution of conflicting priorities.
Knowledge of specification, selection, and purchasing of equipment systems and materials used in bulk pharmaceutical chemicals and specialty chemical processing.
Ability to perform engineering calculations related to process and equipment design.
Knowledge of qualification and validation systems, including test protocols, execution, and reports.
Working knowledge and application of QSHE regulatory compliance principles for chemical and pharmaceutical manufacturing, including FDA, cGMP, EPA, OSHA, and PSM requirements.
Working knowledge of business and finance, including ROI and IRR analysis, cash flow, and committed versus actual costs as applied to project management.
Knowledge of supporting departments’ procedures and systems, such as purchasing, management of change, and SAP.
Ability to communicate technical and business concepts through reports, proposals, instructions, briefings, presentations, technical meetings, training, and negotiations with internal and external representatives.
Ability to read and interpret scientific and technical journals, financial reports, and legal documents; respond to inquiries or complaints; and present information to management, public groups, and technical staff.
Ability to comprehend and apply advanced calculus, modern algebra, advanced statistical theory, and basic accounting and financial principles.
Ability to apply logical or scientific thinking to complex practical problems and work with abstract and concrete variables.
Ability to travel domestically and internationally.
Ability to meet the stated physical demands, with reasonable accommodations where applicable.

Nice To Haves

Stays current with processing-related equipment, technology, and innovations through trade journals, supplier contacts, and professional organizations.
Ability to generate and implement novel ideas and methods to meet site and project needs.

Responsibilities

Develop project business cases and objectives with project owners and supporting staff; evaluate alternatives and build stakeholder and management consensus for recommended solutions.
Review project designs for compliance with engineering principles, company standards, customer contract requirements, and related specifications; evaluate the feasibility and soundness of proposed engineering designs and procedures.
Plan, develop, coordinate, and direct engineering efforts for assigned projects.
Direct development of cost estimates and capital requests; manage purchasing and contracting to secure timely, cost-effective equipment and services.
Ensure project cost, scope, schedule, and quality requirements are met.
Develop and evaluate plans and criteria for project activities carried out by others, and secure resources for technical studies, system design, specifications, construction, and qualification.
Resolve disputes and conflicts with external contractors, vendors, and stakeholders in a timely manner.
Oversee project qualifications, including operational performance, and ensure delivery of specified project performance.
Manage project activities including user requirement specification input and review, scope development, process design, funding requests, equipment standards and specifications, project controls, implementation logistics, engineering design and performance problem resolution, construction supervision, building permits, and qualification and validation.
Provide leadership and management to assigned projects; develop scopes, justifications, cost budgets, personnel requirements, and timelines.
Provide direction to contract engineers and foster a project team atmosphere that supports positive employee morale.
Perform job duties safely and follow applicable quality and cGMP procedures.
Travel domestically and internationally.

Benefits

401(k) matching: the company contributes 100% of the first 6%, with 100% vesting 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.
Three weeks of vacation in the first year.
Vision Insurance.